check_circleStudy Completed

Heart Failure

Study to evaluate the efficacy (effect on disease) and safety of finerenone on morbidity (events indicating disease worsening) & mortality (death rate) in participants with heart failure and left ventricular ejection fraction (proportion of blood expelled per heart stroke) greater or equal to 40%

Trial purpose

The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient’s lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.

Key Participants Requirements

Sex

All

Age

40 - N/A
  • - Participant (male or female) must be aged 40 years and older.
    - Diagnosis of heart failure with New York Heart Association(NYHA) class II–IV, ambulatory or hospitalized primarily for heart failure.
    - On diuretic treatment for at least 30 days prior to randomization.
    - Documented left ventricular ejection fraction (LVEF) of ≥40% measured by any modality within the last 12 months.
    - Structural heart abnormalities based on any local imaging measurement within the last 12 months, defined by at least one of the following findings: left atrial diameter (LAD) ≥3.8cm, left atrial area (LAA) ≥20cm2, left atrial volume index (LAVI) >30 mL/m2, left ventricular mass index (LVMI) ≥115 g/m2 (♂)/ 95 g/m2 (♀), septal thickness or posterior wall thickness ≥1.1 cm
    - n-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥300 pg/mL (BNP ≥100 pg/mL) in sinus rhythm and patient does not have an ongoing diagnosis of paroxysmal atrial fibrillation or NT-proBNP ≥900 pg/mL (BNP ≥300 pg/mL) in atrial fibrillation (or if atrial fibrillation status is unknown or if patient has an ongoing diagnosis of paroxysmal atrial fibrillation) for participants obtained at the following time:

    • Within 90 days prior to randomization if patient had been hospitalized for heart failure (HF) requiring initiation or change in HF therapy or if patient had an urgent visit for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization OR
    • Within 30 days prior to randomization if patient has not been hospitalized for HF nor had an urgent HF visit within the past 90 days.

    - Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and baseline and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.

  • - Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m² at either screening or randomization visit.
    - Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.
    - Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to randomization
    - Myocardial infarction or any event which could have reduced the ejection fraction within 90 days prior to randomization
    - Coronary artery bypass graft surgery in the 90 days prior to randomization
    - Percutaneous coronary intervention in the 30 days prior to randomization
    - Stroke or transient ischemic cerebral attack within 90 days prior to randomization
    - Probable alternative cause of participants’ HF symptoms that in the opinion of the investigator primarily accounts for patient’s dyspnea such as significant pulmonary disease, anemia or obesity. Specifically, patients with the below are excluded: Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy, History of primary pulmonary arterial hypertension, Hemoglobin <10 g/dl, Valvular heart disease considered by the investigator to be clinically significant, Body Mass Index (BMI) >50 kg/m2 at screening
    - Systolic blood pressure(SBP) ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at least 2-minute apart, at screening or at randomization.
    - Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin) or moderate or potent CYP3A4 inducers, that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period.

Trial summary

Enrollment Goal
6016
Trial Dates
September 2020 - June 2024
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
ASST Spedali Civili di BresciaBrescia, 25123, Italy
Completed
ASST Papa Giovanni XXIIIBergamo, 24127, Italy
Completed
IRCCS Centro Cardiologico MonzinoMilano, 20138, Italy
Completed
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.Milano, 20089, Italy
Completed
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
Fondazione IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
IRCCS Istituti Clinici Scientifici Maugeri SpA SBMilano, 20138, Italy
Completed
AUSL Toscana Sud-EstArezzo, 52044, Italy
Completed
AUSL di BolognaBologna, 40133, Italy
Completed
A.O.U. Policlinico Federico II NapoliNapoli, 80131, Italy
Completed
AUSL di PiacenzaPiacenza, 29121, Italy
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
ASST della BrianzaMonza Brianza, 20871, Italy
Withdrawn
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Completed
A.O.U. di FerraraFerrara, 44124, Italy
Completed
A.O.U. Maggiore della CaritàNovara, 28100, Italy
Completed
Capital Region | Gentofte Hospital - Cardiology ResearchHellerup, 2900, Denmark
Completed
Region Midtjylland | Regionshospitalet Godstrup - Clinic for Heart ResearchHerning, 7400, Denmark
Completed
Sydvestjysk Sygehus Esbjerg | Kardiologisk ForskningsenhedEsbjerg, 6700, Denmark
Completed
Odense University Hospital | Svendborg Hospital - Cardiovascular Research UnitSvendborg, 5700, Denmark
Completed
Centro de Investigaciones ClínicasCABA, C1018DES, Argentina
Completed
Centro de Investigaciones Clinicas del LitoralSanta Fe, S3000FWO, Argentina
Completed
Instituto de Investigaciones Clínicas ZárateZárate, B2800DGH, Argentina
Completed
Clínica Privada del PradoCórdoba, X5000AAX, Argentina
Completed
Sanatorio Modelo QuilmesQuilmes, TBC, Argentina
Completed
Corporación Médica de General San MartínSan Martín, 1650, Argentina
Completed
IMOBA Investigaciones ClinicasCABA, C1179AAB, Argentina
Completed
Instituto Médico de la Fundación Estudios ClinicosRosario, S2000DEJ, Argentina
Completed
Chung Nam National University HospitalDaejeon, 35015, Korea, Republic Of
Completed
BUNDANG CHA HOSPITALSeongnam-si, 13496, Korea, Republic Of
Withdrawn
Marienhaus Klinikum MainzMainz, 55131, Germany
Withdrawn
Universitätsklinikum EssenEssen, 45147, Germany
Completed
LLC Medical Centre CONSILIUM MEDICALKyiv, 4050, Ukraine
Completed
Institute of Cardiology AMSKiev, 03680, Ukraine
Completed
Lviv regional clinical medical & diagnostic cardiology centeLviv, 79015, Ukraine
Completed
Medbud-Clinic LLCKyiv, 03037, Ukraine
Completed
Miska Klinichna likarnya No 8Kharkiv, 61176, Ukraine
Completed
City Clinical Hospital # 1Kiev, 02 091, Ukraine
Completed
Institute of Cardiology AMSKiev, 03680, Ukraine
Completed
Institute of Cardiology AMSKiev, 03680, Ukraine
Completed
Regional Clinical Hospital - VinnytsyaVinnytsya, 21018, Ukraine
Completed
Vinnytsia City Clinical Hospital #1Vinnytsia, 21029, Ukraine
Completed
Zakarpatsky Oblasnyi Kardiologichnyi DyspanserUzhgorod, 880000, Ukraine
Completed
Communal Institution Central City Hospital 1 of ZhytomyrZhytomyr, 10002, Ukraine
Completed
National Institute of Therapy named after L.T.MaloyiKharkiv, 61039, Ukraine
Completed
Regional Dispensary of Radiation Protection of PopulationKharkiv, 61166, Ukraine
Completed
"Clinical Emergency Hospital" of Dnipro City CouncilDnipro, 49006, Ukraine
Completed
Zaporizhia Municipal Clinical Hospital No.10Zaporizhzhya, 69001, Ukraine
Completed
Zaporizhzhya City Emergency Care HospitalZaporizhzhya, 69005, Ukraine
Completed
Cherkasy Regional Cardiological CenterCherkasy, 18009, Ukraine
Withdrawn
Clinic of Odesa State Medical UniversityOdessa, 65009, Ukraine
Completed
Kaplan Medical CenterRehovot, 7610001, Israel
Completed
Health Corporation of Galilee Medical CenterNahariya, 22100, Israel
Completed
Barzilai Ashkelon University Medical Center | Cardiology DepartmentAshkelon, 7830604, Israel
Completed
Poria Medical Center | Cardiovascular DepartmentLower Galilee, 15208, Israel
Completed
Tel-Aviv Sourasky Medical CenterTel Aviv, 6423906, Israel
Completed
Health Corporation of the Ziv Medical Center (R.A.)Zefat, 1311001, Israel
Completed
Glasgow Royal Infirmary | Glasgow Clinical Research FacilityGlasgow, G31 2ER, United Kingdom
Completed
Wansbeck General HospitalAshington, NE63 9JJ, United Kingdom
Completed
Royal Bournemouth General HospitalBournemouth, BH7 7DW, United Kingdom
Completed
Lister HospitalStevenage, SG1 4AB, United Kingdom
Completed
Castle Hill HospitalCottingham, HU16 5JQ, United Kingdom
Completed
Russells Hall HospitalDudley, DY1 2HQ, United Kingdom
Completed
St Richard's HospitalChichester, PO19 6SE, United Kingdom
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Chungbuk National University HospitalCheongju-si, 28644, Korea, Republic Of
Completed
Chonnam National University HospitalGwangju, 501-757, Korea, Republic Of
Completed
Severance Hospital, Yonsei University Health SystemSeoul, 03722, Korea, Republic Of
Completed
Dong-A University HospitalBusan, 602-715, Korea, Republic Of
Completed
Hallym University Sacred Heart HospitalAnyang, 431-070, Korea, Republic Of
Completed
Yonsei University Wonju Christian HospitalWonju, 26426, Korea, Republic Of
Completed
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Completed
Herzklinik Ulm GbRUlm, 89077, Germany
Withdrawn
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20246, Germany
Withdrawn
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)Bad Oeynhausen, 32545, Germany
Completed
Städt. Kliniken Bielefeld gGmbHBielefeld, 33604, Germany
Completed
Klinikum der Universität WürzburgWürzburg, 97078, Germany
Withdrawn
Cardiologicum HamburgHamburg, 22041, Germany
Withdrawn
Klinikum Lüdenscheid - Märkische Kliniken GmbHLüdenscheid, 58515, Germany
Withdrawn
Friedrich-Schiller-Uni. JenaJena, 7747, Germany
Withdrawn
Praxis Hr. Dr. med. Jens TaggeselleMarkkleeberg, 04416, Germany
Withdrawn
Bethanien KrankenhausFrankfurt, 60389, Germany
Withdrawn
ASST Valle OlonaVarese, 21047, Italy
Completed
ASST di CremonaCremona, 26100, Italy
Completed
A.O. di PerugiaPerugia, 06129, Italy
Completed
Pusan National University HospitalBusan, 49241, Korea, Republic Of
Completed
Kardio Chlumec s.r.o.- Kardiologicka ambulanceChlumec nad Cidlinou, 503 51, Czechia
Completed
Kardiologicka ambulanceCesky Krumlov, 381 01, Czechia
Completed
Lanzhou University Second HospitalLanzhou, 730030, China
Completed
Mount Sinai HospitalToronto, M5G 1X5, Canada
Completed
Centre Hospitalier de l’Université de Montréal-CHUMMontreal, H2X 0C1, Canada
Completed
Clinique Sante Cardio MCMontreal, H1T 3Y7, Canada
Completed
Dokuz Eylul Universitesi Tip FakultesiIzmir, 35100, Turkey
Completed
Eskisehir Osmangazi Universitesi Tip FakultesiEskisehir, 26480, Turkey
Completed
Mersin Universitesi Tip FakultesiMersin, 33079, Turkey
Completed
Erciyes Universitesi Tip FakultesiKayseri, 38039, Turkey
Completed
Trakya Univ. Tip Fak.Edirne, 22030, Turkey
Completed
Necmettin Erbakan Universitesi Meram Tip Fakultesi HastanesiKonya, 42080, Turkey
Completed
Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.Istanbul, Turkey
Withdrawn
29 Mayis Devlet HastanesiAnkara, 06105, Turkey
Completed
The Second Affiliated Hospital of Nanjing Medical universitynanjing, 210000, China
Completed
Cardiology Associates Research CompanyDaytona Beach, 32117, United States
Completed
Wake Forest Baptist HealthWinston-Salem, 27157-1082, United States
Completed
Capital Area Research, LLCCamp Hill, 17011, United States
Completed
Colorado Springs CardiologyColorado Springs, 80923, United States
Completed
Carolina Heart Specialists | LancasterLancaster, 29720, United States
Completed
Fakultni Nemocnice Hradec KraloveHradec kralove, 500 05, Czechia
Completed
Fakultni nemocnice v MotolePraha 5, 150 06, Czechia
Completed
Poliklinika Dolni BrezanyDolni Brezany, 252 41, Czechia
Completed
Shamir Medical Center (Assaf Harofeh)Zrifin, 7030000, Israel
Completed
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Cardiology DepartmentVeliko Tarnovo, 5000, Bulgaria
Completed
MHAT Hadzhi DimitarSliven, 8800, Bulgaria
Completed
MHAT HaskovoHaskovo, 6300, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Sveta Karidad | Cardiology DepartmentPlovdiv, 4004, Bulgaria
Completed
MHAT TrakiaStara Zagora, 6000, Bulgaria
Completed
Medical centre Hipokrat - N EOODPlovdiv, 4000, Bulgaria
Completed
NMTH Tzar Boris IIISofia, 1233, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Sveti Panteleymon Yambol | Cardiology DepartmentYambol, 8600, Bulgaria
Completed
Medical Center HeraSofia, 1510, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Medline | Cardiology DepartmentPlovdiv, 4000, Bulgaria
Completed
Medical Center Medconsult PlevenPleven, 5800, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology DepartmentSofia, 1233, Bulgaria
Completed
Second Medical Center Sofia EOODSofia, 1202, Bulgaria
Completed
¿ultidisc. hosp. for act. treatm. Sveti Georgi - Pernik OODPernik, 2300, Bulgaria
Completed
MHAT ZdravePazardjik, 4400, Bulgaria
Completed
Ambulatory facility for specialized outpatient medical careBurgas, 8000, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Sveta Sofia | Internal Diseases DepartmentSofia, 1618, Bulgaria
Completed
Multiprofile Hospital for Active Treatment | Shumen - First Department of Internal MedicineShumen, 9700, Bulgaria
Completed
MHAT National Cardiology Hospital EADSofia, 1309, Bulgaria
Completed
UMHAT Tsaritsa Joanna-ISUL EAD SofiaSofia, 1527, Bulgaria
Withdrawn
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Completed
Centro Hospitalar Universitario Cova de Beira | Clinical Research DepartmentCovilha, 6200-251, Portugal
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Krankenhaus St. Josef BraunauBraunau, 5280, Austria
Completed
Shanghai Tongji Hospital of Tongji UniversityShanghai, China
Completed
Institut Klinicke a Experimentalni MedicinyPraha 4, 140 21, Czechia
Completed
Vseobecna fakultni nemocnice v PrazePraha 2, 12808, Czechia
Completed
Fakultni nemocnice BrnoBrno, 625 00, Czechia
Completed
Kromerizska nemocnice a.s.Kromeriz, 767 55, Czechia
Completed
Rambam Health CorporationHaifa, 3109601, Israel
Completed
Afyonkarahisar Saglik Bilimleri UniversitesiAfyonkarahisar, 03218, Turkey
Completed
Kutahya Saglik Bilimleri Uni. Evliya Celebi Egitim ve ArastiKutahya, 43040, Turkey
Completed
Beijing Anzhen Hospital, Capital Medical UniversityBeijing, 100029, China
Completed
Beijing Friendship Hospital, Capital Medical UniversityBeijing, 100050, China
Completed
West China Hospital Sichuan UniversityChengdu, 610041, China
Completed
Fujian Provincial HospitalFuzhou, 350001, China
Completed
A.O.U.I. VeronaVerona, 37126, Italy
Completed
ASST Sette LaghiVarese, 21049, Italy
Completed
ASST di MonzaMonza Brianza, 20090, Italy
Completed
Ustredni vojenska nemocnice PrahaPraha 6, 169 02, Czechia
Completed
KardioBusak s.r.o.Louny, 440 01, Czechia
Completed
Kardiologicka ambulance Brno s.r.o.Brno, 612 00, Czechia
Completed
Kardio s.r.o.Trebic, 67401, Czechia
Completed
Kardiologie MUDr. Libor Nechvatal s.r.o.Brno, 602 00, Czechia
Completed
Angiocor s.r.o.Zlin, 760 01, Czechia
Completed
Fakultni nemocnice PlzenPlzen, 301 00, Czechia
Withdrawn
Mestska nemocnice Ostrava-City Hospital OstravaOstrava, 728 80, Czechia
Completed
Campinas Clinical Research Institute (IPECC) | Campinas, BrazilCampinas, 13060-080, Brazil
Completed
Women's College HospitalToronto, M5F 1B2, Canada
Withdrawn
CHUS - Ctr Hosp Univer de Sherbrooke - Hopital Hotel-DieuSherbrooke, J1G 2E8, Canada
Completed
St. Boniface HospitalWinnipeg, R2H 2A6, Canada
Completed
People's Hospital of Xinjiang Uygur Autonomous RegionUrumqi, 830001, China
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
La Fe University and Polytechnic Hospital | Cardiology DepartmentValencia, 46026, Spain
Completed
Hospital Sanitas La Zarzuela | CardiologiaMadrid, 28023, Spain
Completed
Complejo Hospitalario Ntra. Sra. de ValmeSevilla, 41014, Spain
Completed
Hospital de ManisesValencia, 46940, Spain
Completed
Hospital Universitario Virgen de la Victoria | Cardiology DepartmentMalaga, 29010, Spain
Completed
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke PreventionL'Hospitalet de Llobregat, 08907, Spain
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Hospital Alta Resolucion de Utrera | Cardiology Service DepartmentUtrera, 41710, Spain
Completed
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital San RafaelSalvador, 41253-190, Spain
Completed
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión ArterialFerrol, 15405, Spain
Completed
Hospital General Universitario de ValenciaValencia, 46014, Spain
Completed
Hospital Central de AsturiasOviedo, 33011, Spain
Completed
Hospital Universitario Virgen de las Nieves|CardiologiaGranada, 18014, Spain
Completed
Hospital Dr. NegrínLas Palmas de Gran Canaria, 35020, Spain
Completed
Jose Manuel Pascual Pascual S.A. | Hospital Virgen de las Montanas - Internal Medicine DepartmentVillamartin, 11650, Spain
Completed
Jose Manuel Pascual Pascual S.A. | Hospital Virgen del Camino - Internal Medicine DepartmentSanlucar de Barrameda, 11540, Spain
Completed
Hospital Santa María del PuertoEl Puerto de Santa María, 11500, Spain
Completed
Hospital Universitario Arnau de Vilanova de LleidaLleida, 25198, Spain
Completed
Hospital Ramón y Cajal | Medicina InternaMadrid, 28034, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Withdrawn
Hospital Clinico Universitario San Carlos | Medicina InternaMadrid, 28040, Spain
Completed
Hospital del Servei Valencià de Salud de la Vega BajaSan Bartolomé, 3314, Spain
Completed
The First Hospital of Hebei Medical UnivesityShijiazhuang, 50000, China
Withdrawn
Hamilton Health Sciences - General SiteHamilton, L8L 2X2, Canada
Completed
Oakville Cardiovascular ResearchOakville, L6K 3W7, Canada
Completed
Hvidovre HospitalHvidovre, 2650, Denmark
Completed
Holbæk SygehusHolbæk, 4300, Denmark
Completed
Aarhus Universitetshospital, SkejbyAarhus N, 8200, Denmark
Completed
Capital Region | Herlev Hospital - Department of Heart DiseaseHerlev, 2730, Denmark
Completed
Meir Medical CenterKfar Saba, 4428164, Israel
Completed
Centro Hospitalar de Lisboa Ocidental | Clin Res DeptLisboa, 1449-005, Portugal
Completed
Centro Hospitalar Universitario do PortoPorto, 4099-001, Portugal
Completed
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao ClinicaLisboa, 1500-650, Portugal
Completed
Centro Hospitalar de Leiria | Santo Andre Hospital - Research CenterLeiria, 2410-197, Portugal
Completed
Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Cardiology, Research UnitCoimbra, 3004-561, Portugal
Completed
BlueClinical | Centro Hospitalar Baixo Vouga - Unidade Aveiro - Gabinete de Ensaios ClinicosAveiro, 3810-501, Portugal
Completed
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato KorhazSzekesfehervar, 8000, Hungary
Completed
Nagykanizsai Kanizsai Dorottya KorhazNagykanizsa, 8800, Hungary
Withdrawn
Gottsegen Gyorgy Orszagos Kardiovaszkularis IntezetBudapest, 1096, Hungary
Completed
University of Semmelweis/ Semmelweis EgyetemBudapest, 1122, Hungary
Completed
Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.Nyiregyhaza, 4400, Hungary
Completed
Cardiomobile Egeszsegugyi Szolgaltato Kft.Balatonfured, 8230, Hungary
Completed
Tolna Varmegyei Balassa Janos KorhazSzekszard, 7100, Hungary
Completed
Csongrad-Csanad Megyei Dr. Bugyi Istvan KorhazSzentes, 6600, Hungary
Completed
Csongrad-Csanad Varmegyei Egeszsegugyi Ellato Kozpont Hodmezovasarhelyi TagintezmenyHodmezovasarhely, 6800, Hungary
Completed
Pharma4Trial Kft.Gyongyos, 3200, Hungary
Completed
University of Semmelweis/ Semmelweis EgyetemBudapest, 1085, Hungary
Completed
Da Vinci MaganklinikaPecs, 7635, Hungary
Completed
Budapesti Jahn Ferenc Del-pesti Korhaz es RendelointezetBudapest, 1204, Hungary
Completed
COROMED SMO KFTPecs, 7623, Hungary
Completed
Eszak-Pesti Centrumkorhaz-HonvedkorhazBudapest, Hungary
Completed
Clinica Cardio VIDMedellin, 050034, Colombia
Completed
Sociedad Médica Rionegro SOMER S.A.Rionegro, 054040, Colombia
Completed
Clínica Imbanaco S.A.SCali, 760042, Colombia
Completed
IPS Centro Cientifico Asistencial S.A.SBarranquilla, 080020, Colombia
Completed
Mediservis del Tolima IPS S.A.SIbague, 730006, Colombia
Completed
Hospital Universitario Clínica San RafaelBogota, 110621, Colombia
Completed
Unicardia Specjalistyczne Centrum Leczenia Ch.Serca i NaczynKrakow, 31-271, Poland
Completed
MICS Centrum Medyczne BydgoszczBydgoszcz, 85-065, Poland
Withdrawn
Wojewodzki Specjalistyczny Szpital im. dr Wl. BieganskiegoLodz, 91-347, Poland
Completed
Gessek Jacek Prywatny Gabinet LekarskiTorun, 87-100, Poland
Completed
KLIMED Marek KlimkiewiczBialystok, 15-704, Poland
Completed
Szpital Specjalistyczny SPZOZPulawy, 24-100, Poland
Completed
Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.Oswiecim, 32-600, Poland
Completed
NZOZ Pro-Cordis Sopockie Centrum Badan KardiologicznychSopot, 81-717, Poland
Completed
CLINICAL MEDICAL RESEARCH Sp. z o. o.Katowice, 40-156, Poland
Completed
NZOZ "Twoja Przychodnia" Sp. z o.o.Lublin, 20-857, Poland
Completed
Twoja Przychodnia - Szczecinskie Centrum MedyczneSzczecin, 71-434, Poland
Completed
Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, 61-848, Poland
Withdrawn
Szpital Uniwersytecki Nr 2 im. J. BizelaBydgoszcz, 85-168, Poland
Completed
IMEDICA Centrum MedyczneLublin, 20-068, Poland
Completed
Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdynia, Poland
Withdrawn
Medicor PLUS Kardiolodzy sp. z o. o.Wloclawek, 87-800, Poland
Completed
Zechowicz Medeusz-Plus Lekarska Spolka PartnerskaOlsztyn, 10-010, Poland
Withdrawn
NZOZ Terapia OptimaKatowice, 40-752, Poland
Completed
Samodzielny Publiczny Specjalistyczny Szpital ZachodniGrodzisk Mazowiecki, 05-825, Poland
Completed
University General Hospital ATTIKONChaidari, 12462, Greece
Completed
G. GENNIMATAS General State Hospital of AthensAthens, 11527, Greece
Completed
Konstantopoulio General Hospital of Nea Ionia - AGIA OLGANea Ionia / Athens, 142 33, Greece
Completed
KAT General Hospital of AthensKifisia / Athens, 14561, Greece
Completed
Klinik Floridsdorf - Krankenhaus NordWien, 1210, Austria
Completed
Universitätsklinikum St. PöltenSt. Pölten, 3100, Austria
Completed
Uniklinikum Salzburg - LandeskrankenhausSalzburg, 5020, Austria
Completed
Klinikum Klagenfurt am WörtherseeKlagenfurt, 9020, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Landeskrankenhaus FeldkirchFeldkirch, 6807, Austria
Completed
East Coast Institute for Research | St. Augustine, FLSt. Augustine, 32086, United States
Completed
Hospital das Clinicas da Universidade Federal de Goias | Centro de Pesquisa em CardiologiaGoiânia, 74605-020, Brazil
Completed
Hospital Mae de DeusPorto Alegre, 90110-000, Brazil
Completed
Sociedade Hospitalar Angelina Caron | Departamento de Ensino e PesquisaParaná, 83430-000, Brazil
Completed
Santa Casa de Misericórdia da BahiaSalvador, 40050-410, Brazil
Completed
Hospital Felício RochoBelo Horizonte, 30110-130, Brazil
Completed
Centro Avançado de Pesquisa para Diagnóstico - CAPEDRibeirão Preto, 14026-020, Brazil
Completed
Interventional Cardiology Medical Group | West Hills, CAWest Hills, 91307, United States
Completed
Garden State Heart CareManalapan, 07726, United States
Completed
Maryland Cardiovascular SpecialistsBaltimore, 21229, United States
Completed
National Heart InstituteBeverly Hills, 90211-2285, United States
Completed
Kocaeli Universitesi Tip FakultesiKocaeli, 41380, Turkey
Completed
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med SchoolNanjing, 210008, China
Completed
The First Hospital of Jilin UniversityChangchun, 130000, China
Completed
Beijing Tsinghua Changgung HospitalBeijing, 102218, China
Completed
G.A. Research Associates, Ltd.Moncton, E1G 1A7, Canada
Withdrawn
Universitätsklinikum des SaarlandesHomburg, 66421, Germany
Withdrawn
Universitätsklinikum GreifswaldGreifswald, 17475, Germany
Withdrawn
Kardiologische Praxis EilenburgEilenburg, 4838, Germany
Completed
MEDI M&M, s.r.o.Moldava nad Bodvou, 045 01, Slovakia
Completed
Medical Group Kosice s.r.o. | Kosice, SlovakiaKosice, 040 01, Slovakia
Completed
KardioMed s.r.o.Lucenec, 984 01, Slovakia
Terminated
JG-COR s.r.o.Kosice, 040 01, Slovakia
Completed
MEDISPOL s.r.o.Presov, 080 01, Slovakia
Completed
ALIAN s.r.o.Bardejov, 085 01, Slovakia
Completed
COR, s.r.oSahy, 936 01, Slovakia
Completed
Deventer ZiekenhuisDeventer, 7416 SE, Netherlands
Completed
Ziekenhuis Groep TwenteALMELO, 7609 PP, Netherlands
Completed
LUNACOR, Centrum pro choroby srdce a cevKromeriz, 767 01, Czechia
Completed
Corazón IPS S.A.S.Barranquilla, Colombia
Completed
Medivasa s.r.o.Zilina, 01001, Slovakia
Completed
Nemocnica s poliklinikou Brezno, n.o.Brezno, 977 01, Slovakia
Completed
Kardiocentrum Nitra | Cardiology Clinic - Outpatient DepartmentNitra, 94901, Slovakia
Completed
KARDIO-ANGIO s.r.o.Levice, 934 01, Slovakia
Completed
KARDIOMED NZ s.r.o.Nove Zamky, 940 01, Slovakia
Completed
Dolnooravska nemocnica s poliklinikou L. Nadasi JegehoDolny Kubin, 026 14, Slovakia
Completed
Stredoslovensky ustav srdcovych a cievnych chorob, a.s.Banska Bystrica, 974 01, Slovakia
Completed
Chaim Sheba Medical CenterRamat Gan, 52621, Israel
Completed
Centro de Especialidades Medicas (Cemedic) | Cardiology DepartmentVilla Luro, C1440CFD, Argentina
Completed
Instituto de Cardiologia | Tucuman, ARSan Miguel de Tucuman, 4000, Argentina
Completed
Centro de Investigaciones MetabólicasBuenos Aires, C1056ABJ, Argentina
Completed
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Terminated
Nemocnica svateho Michala, a.s.Bratislava, 811 08, Slovakia
Withdrawn
Dalian Central HospitalDalian, 116033, China
Completed
University Hospitals LeicesterLeicester, LE3 9QP, United Kingdom
Completed
Istanbul Universitesi Kardiyoloji EnstitusuIstanbul, 34304, Turkey
Completed
Saglik Bilimleri Universitesi Antalya EA HastanesiAntalya, 7100, Turkey
Completed
Hospital Alma Mater de AntioquiaMedellín, Colombia
Completed
Kawartha Cardiology Clinical TrialsPeterborough, K9J 0B2, Canada
Completed
Office of Dr. James Cha, MDOSHAWA, L1J 2K1, Canada
Completed
Centre intégré de santé et de services sociaux de Laval, HôpLaval, H7M 3L9, Canada
Completed
Fraser Clinical Trials, Inc.New Westminster, V3L 3W4, Canada
Withdrawn
Centre Integre de sante et de services sociaux de LanaudiereTerrebonne, J6V 2H2, Canada
Completed
Christchurch Heart InstituteChristchurch, 8140, New Zealand
Completed
Logan Health ResearchKalispell, 59901, United States
Completed
Krajska Nemocnice LiberecLiberec, 460 63, Czechia
Completed
Queen Elizabeth University HospitalGlasgow, G51 4TF, United Kingdom
Completed
London Health Sciences CentreLondon, N5R 6M6, Canada
Completed
Montreal General HospitalMontreal, H4A 3J1, Canada
Completed
Cambridge Cardiac Care CenterCambridge, N1R 6V6, Canada
Completed
Narodny ustav srdcovych a cievnych chorob, a.sBratislava 37, 833 48, Slovakia
Completed
Centrum interv. neuroradiologie a endovaskularnej liecbyBratislava, 84103, Slovakia
Completed
Kardiosanus | Bratislava, SlovakiaBratislava, 84107, Slovakia
Completed
Univerzitna nemocnica Bratislava, Nemocnica Stare MestoBratislava, 813 69, Slovakia
Completed
Poltava Regional Clinical Hospital n.a. M.V. SkliphosovskyiPoltava, 36011, Ukraine
Completed
Regional medical center of cardio-vascular diseaseZaporizhzhja, 69005, Ukraine
Completed
Railway Clinical Hospital #2Kyiv, 3049, Ukraine
Withdrawn
Cardiology Consultants of Orange CountyAnaheim, 92801, United States
Completed
Fundación CardioinfantilBogota, 110131, Colombia
Completed
Caja de Compensación Familiar CAFAMBogota, 111061, Colombia
Completed
Rodrigo Botero S.A.SMedellin, 050021, Colombia
Completed
Louisiana Heart Center Research - SlidellSlidell, 70458, United States
Completed
Methodist Medical Center of IllinoisPeoria, 61606, United States
Completed
CHI Health Nebraska HeartLincoln, 68526, United States
Completed
Saratoga Clinical Research, LLCSaratoga Springs, 12866, United States
Completed
Lady Davis Carmel Medical CenterHaifa, 3436212, Israel
Completed
Assuta AshdodAshdod, 7747629, Israel
Completed
Bnai Zion Medical Center | Cardiology DepartmentHaifa, 3339419, Israel
Completed
Clínica Coronel SuarezCoronel Suarez, B7540GHD, Argentina
Completed
Inst. de Cardiología de Corrientes Juana Francisca CabralCorrientes, 3400, Argentina
Completed
Centro de Investigaciones Medicas Lanus | Research DepartmentLanus, B1824, Argentina
Completed
Hospital Militar Central "CIR. MY. C. Argerich"Buenos Aires, 1426, Argentina
Completed
Hospital Italiano de La Plata | Clinical Research DepartmentLa Plata, B1900, Argentina
Completed
Instituto Médico DAMIC- Fundación RusculledaCórdoba, X5003DCE, Argentina
Completed
Instituto Cardiovascular de Buenos Aires - Buenos Aires, ArgentinaBuenos Aires, C1428ART, Argentina
Completed
Instituto CardiovascularRosario, 2000, Argentina
Completed
Jilin Province People's HospitalChangchun, 130021, China
Completed
Sutter Heart & Vascular InstituteSacramento, 95816, United States
Completed
University General Hospital of LarissaLarissa, 41110, Greece
Withdrawn
AHEPA University General Hospital of ThessalonikiThessaloniki, 546 36, Greece
Withdrawn
Ioannina University General HospitalIoannina, 45500, Greece
Completed
University General Hospital of AlexandroupolisAlexandroupoli, 68100, Greece
Completed
General Hospital of Athens "ALEXANDRA"Athens, 11528, Greece
Completed
Dunedin HospitalDunedin, 9016, New Zealand
Completed
University of Mississippi Medical CenterJackson, 39216-4505, United States
Completed
IMG Cardiology- FairfaxFairfax, 22031, United States
Completed
Cardiovascular Research of KnoxvillePowell, 37849, United States
Completed
Apex Cardiology, LLCJackson, 38301, United States
Completed
Selma Medical AssociatesWinchester, 22601, United States
Completed
Higashi Takarazuka Satoh HospitalTakarazuka, 665-0873, Japan
Completed
Fukuoka University Nishijin HospitalFukuoka, 814-8522, Japan
Completed
Minamino Cardiovascular HospitalHachioji, 192-0918, Japan
Completed
Oita Prefectural HospitalOita, 870-8511, Japan
Completed
Steel Memorial Yawata HospitalKitakyushu, 805-8508, Japan
Completed
Shinrakuen HospitalNiigata, 950-2087, Japan
Completed
The Sakakibara Heart Institute of OkayamaOkayama, 700-0804, Japan
Completed
Takatsuki Red Cross HospitalTakatsuki, 569-1096, Japan
Completed
TOYOTA Memorial HospitalToyota, 471-8513, Japan
Completed
JCHO Shimonoseki Medical CenterShimonoseki, 750-0061, Japan
Completed
Mitoyo General Hospital | Kagawa, JapanKanonji, 769-1695, Japan
Completed
Nishiarai Heart Central ClinicAdachi-ku, 123-0845, Japan
Completed
Miyazaki Medical Association HospitalMiyazaki, 880-2102, Japan
Completed
Saitama Sekishinkai HospitalSayama, 350-1305, Japan
Completed
Japan Red Cross Society Azumino HospitalAzumino, 399-8292, Japan
Completed
Kasugai Municipal HospitalKasugai, 486-8510, Japan
Completed
Toho University Omori Medical CenterOta-ku, 143-8541, Japan
Completed
National Hospital Organization Hamada Medical CenterHamada, 697-8511, Japan
Completed
National Hospital Organization Iwakuni Clinical CenterIwakuni, 740-8510, Japan
Completed
National Hospital Organization Kanazawa Medical Center | Clinical Trial Management OfficeKanazawa, 920-8650, Japan
Completed
National Hospital Organization Shinshu Ueda Medical CenterUeda, 386-8610, Japan
Completed
Moscow State University n.a. M.V. LomonosovMoscow, 119192, Russian Federation
Completed
Samara Regional Clinical Cardiology Dispensary n.a. PolyakovSamara, 443070, Russian Federation
Completed
St. Petersburg Clinical Hospital of RASSt. Petersburg, 194017, Russian Federation
Withdrawn
City hospital #15St. Petersburg, 198205, Russian Federation
Completed
Perm Regional Hospital for War VeteransPerm, 614097, Russian Federation
Completed
Research center of therapy and prophylactic medicineMoscow, 101990, Russian Federation
Completed
Penza Regional Clinical Hospital n.a. N.N. BurdenkoPenza, 440026, Russian Federation
Completed
City Clinical Hospital #51Moscow, 121309, Russian Federation
Withdrawn
City Pokrovskaya HospitalSt. Petersburg, 199106, Russian Federation
Completed
City clinical hospital n.a. V.V. VinogradovMoscow, 117292, Russian Federation
Completed
Scien. Res. Inst. of Emergency Care n.a. I.I. DzhanelidzeSt. Petersburg, 192242, Russian Federation
Withdrawn
RBHI "Cardiological Dispensary"Ivanovo, 153012, Russian Federation
Completed
Omsk Region “Clinical Health Unit No. 9”Omsk, 644018, Russian Federation
Completed
SBHI of Sverdlovsk Region Aramil City HospitalAramil, 624003, Russian Federation
Completed
Sci-Res. Institute of Complex Cardiovascular DisordersKemerovo, 650002, Russian Federation
Completed
Scientific Research Institute of CardiologyTomsk, 634012, Russian Federation
Completed
First City Clinical Hospital n.a. E.E. VolosevichArkhangelsk, 163001, Russian Federation
Completed
Izhevsk City Clinical Hospital #9Izhevsk, 426063, Russian Federation
Completed
Rostov-on-Don Emergency Clinical HospitalRostov-on-Don, 344068, Russian Federation
Completed
Center of cardiology and neurologyKirov, 610014, Russian Federation
Completed
Tomsk Regional Clinical HospitalTomsk, 634063, Russian Federation
Completed
Altai Regional Cardiological DispensaryBarnaul, 656055, Russian Federation
Completed
SBEI "Chita State Medical Academy"Chita, 672000, Russian Federation
Completed
State Novosibirsk Regional Clinical HospitalNovosibirsk, 630087, Russian Federation
Completed
Kazan Federal UniversityKazan, 420008, Russian Federation
Completed
Clinical Hospital #3 n.a. S.R. MirotvortsevSaratov, 410054, Russian Federation
Completed
LLC AstartaSt. Petersburg, 199226, Russian Federation
Completed
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHosChengdu, 610072, China
Completed
The First Affiliated Hospital of Xinjiang Medical UniversityUrumqi, 830054, China
Completed
AA MRC, LLCFlint, 48504, United States
Completed
Eastern Shore Research Institute, LLC | Fairhope, ALFairhope, 36532, United States
Completed
Advanced Heart Care, LLC | Bridgewater, NJBridgewater, 08807, United States
Completed
Northwest Houston Heart CenterTomball, 77375, United States
Completed
The Stern Cardiovascular Foundation, Inc.Germantown, 38138, United States
Completed
Cardiac Care & Vascular MedicineBronx, 10469, United States
Completed
Daqing Oilfield General HospitalDaqing, 163311, China
Completed
Guangdong Provincial People's HospitalGuangzhou, 510100, China
Completed
The First Affiliated Hospital of Guangzhou University of TCMGuangzhou, 510405, China
Completed
Southwest Family Medicine AssociatesDallas, 75235, United States
Completed
National Taiwan University HospitalTaipei, 100, Taiwan
Completed
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Completed
Taipei Medical University HospitalTaipei, 110, Taiwan
Completed
Chang Gung Memorial Hospital at LinkouTao-Yuan, 333, Taiwan
Completed
Mackay Memorial Hospital - Hsinchu BranchHsinchu, 300, Taiwan
Completed
Taichung Veterans General HospitalTaichung, 1650, Taiwan
Completed
Changhua Christian HospitalChanghua, 50006, Taiwan
Completed
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, 807377, Taiwan
Completed
University of AucklandAuckland, 1023, New Zealand
Completed
IACT HealthColumbus, 31904, United States
Completed
Clinical Advancement Center, PLLCSan Antonio, 78212-4740, United States
Completed
M Health Fairview Heart Clinic - FultonMinneapolis, 55455, United States
Completed
Advocate Condell Medical CenterLibertyville, 60048, United States
Completed
Southwest Florida Research | Naples, FLNaples, 34102-8143, United States
Completed
Clinical Research ConsultantsKansas City, 64111, United States
Withdrawn
Tianjin Chest HospitalTianjin, TBC, China
Completed
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710061, China
Completed
1st Affiliated hospital of Soochow UniversitySuzhou, 215006, China
Completed
Jiangsu Province HospitalNanjing, TBC, China
Completed
Huai'an First People's Hospital, Nanjing Medical UniversityHuai'An, 223300, China
Completed
University of Utah Health CareSalt Lake City, 84132, United States
Withdrawn
University of Iowa Hospitals & ClinicsIowa City, 52242, United States
Withdrawn
Oblastni Nemocnice KladnoKladno, 27259, Czechia
Completed
Kardiologicka a interni ambulancePisek, 39701, Czechia
Completed
Nemocnice ZnojmoZnojmo, 669 02, Czechia
Completed
Nemocnice PodlesiTrinec, 73961, Czechia
Completed
Polabska zdravotni, s.r.o.Podebrady, 290 01, Czechia
Completed
Instituto del Corazón de BucaramangaBucaramanga, 680002, Colombia
Completed
Clínica de la Costa SASBaranquilla, 080020, Colombia
Completed
Fundación Cardiomet CEQUIN Eje CafeteroArmenia, 630004, Colombia
Withdrawn
Hospital Universitario Mayor-MÉDERIBogota, 111411, Colombia
Completed
Hippokration General Hospital of ThessalonikiThessaloniki, 54642, Greece
Completed
Shaanxi Provincial People's HospitalXi'an, 710068, China
Completed
CorcareScarborough, M1B 5N1, Canada
Completed
Vizel Cardiac ResearchCambridge, N1R 7R1, Canada
Completed
Queen Elizabeth II Health Sciences CentreHalifax, B3H 3A7, Canada
Completed
University Malaya Medical CentreKuala Lumpur, 59100, Malaysia
Completed
Institute Jantung NegaraKuala Lumpur, 50400, Malaysia
Completed
Sarawak Heart CentreSarawak, 94300, Malaysia
Completed
Hospital SerdangSelangor, 43000, Malaysia
Completed
Hospital Raja Permaisuri BainunPerak, 30450, Malaysia
Completed
Gleneagles Penang Medical CenterGeorge Town,, 10050, Malaysia
Completed
Hospital Pulau PinangPulau Pinang, 10450, Malaysia
Completed
P3 Research Ltd Hawkes BayHawkes Bay, 4130, New Zealand
Completed
University General Hospital of HeraklionHeraklion, 71110, Greece
Completed
P3 ResearchTauranga, 3110, New Zealand
Completed
Centro de Investigación Médica Dr. Alberto Bazzoni SA de CVTorreón, 27000, Mexico
Completed
Hospital Cardiologica AguascalientesAguascalientes, 20230, Mexico
Completed
Centro de Investigacion y Atencion Integral Durango S.C.Durango, 34080, Mexico
Completed
Hospital Ángeles de XalapaXalapa, 91193, Mexico
Completed
Centro de Estudios Clinicos de Queretaro S. C. (CECLIQ)Queretaro, 76000, Mexico
Completed
Hyogo Brain and Heart CenterHimeji, 670-8560, Japan
Completed
Japan Organization of Occupational Health and Safety Sanin Rosai HospitalYonago, 683-8605, Japan
Withdrawn
Hospital Central "Dr. Ignacio Morones Prieto"San Luis Potosí, 78240, Mexico
Completed
Fundación de Atencion e Investigacion Medica Lindavista SCAlcaldia Gustavo A. Madero, 7300, Mexico
Completed
Hospital de JesúsAlcaldía Cuauhtemoc, 06090, Mexico
Completed
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Completed
LUHS Kauno Hospital (Laisves ave.)Kaunas, LT-44320, Lithuania
Completed
LUHS Kauno Hospital (Josvainiu str.)Kaunas, LT-47144, Lithuania
Withdrawn
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Completed
Klaipedos Jurininku LigonineKlaipeda, LT-92288, Lithuania
Completed
Saules family medicine centerKaunas, LT-49449, Lithuania
Completed
UAB "Klinikiniai sprendimai" AlytusAlytus, LT-63200, Lithuania
Completed
Siauliai Republican hospitalSiauliai, 76231, Lithuania
Withdrawn
PI Kedainiai HospitalKedainiai, LT-57164, Lithuania
Completed
Kishiwada Tokushukai HospitalKishiwada, 596-0042, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Gifu Prefectural General Medical CenterGifu, 500-8717, Japan
Completed
Shobara Red Cross HospitalShobara, 727-0013, Japan
Completed
Ageo Central General HospitalAgeo, 362-8588, Japan
Completed
Onga Nakama Medical Association Onga HospitalOnga-gun, 811-4342, Japan
Completed
Seiyu Memorial HospitalWakayama, 649-6335, Japan
Completed
Social Corporation Keigakukai Minamiosaka HospitalOsaka, 559-0012, Japan
Withdrawn
Saga-Ken Medical Centre KoseikanSaga, 840-8571, Japan
Completed
National Hospital Organization Kumamoto Medical CenterKumamoto, 860-0008, Japan
Completed
National Hospital Organization Kobe Medical CenterKobe, 654-0155, Japan
Withdrawn
Hospital SISMANOGLIOMarousi, 15126, Greece
Completed
Hutt HospitalLower Hutt, 5010, New Zealand
Completed
Catharina ZiekenhuisEINDHOVEN, 5623 EJ, Netherlands
Completed
Ziekenhuis Gelderse ValleiEde, 6716 RP, Netherlands
Completed
Antonius Ziekenhuis SneekSneek, 8601 ZR, Netherlands
Completed
Isala MeppelMEPPEL, 7943 KA, Netherlands
Completed
Slingeland ZiekenhuisDOETINCHEM, 7009 BL, Netherlands
Completed
Tergooiziekenhuizen-BlaricumBLARICUM, 1261 AN, Netherlands
Completed
NJ Heart | Linden, NJLinden, 07036, United States
Completed
Cardiology, PCBirmingham, 35211, United States
Completed
Seton Heart InstituteAustin, 78705, United States
Completed
Advocate Illinois Masonic Medical CenterChicago, 60657, United States
Completed
PMG Research of CharlestonMt. Pleasant, 29464, United States
Completed
CHI Health Clinic Heart Institute - Grand IslandGrand Island, 68803, United States
Completed
Shanghai East Hospital Affiated to Tongji Universityshanghai, 200100, China
Completed
General Hospital of Ningxia Medical UniversityYinchuan, 750004, China
Completed
Panjin Liaohe Oilfield Gem Flower HospitalPanjin, 124010, China
Completed
General Hosp of Athens "Korgialenio-Benakeio" RCHAmpelokipi - Athens, 11526, Greece
Completed
Great Western HospitalSwindon, SN3 6BB, United Kingdom
Completed
Manchester Royal InfirmaryManchester, M13 9WL, United Kingdom
Completed
The First People's Hospital of LianyungangLianyungang, 222002, China
Completed
Mercy Hospital SpringfieldSpringfield, 65804, United States
Completed
Queen Mary HospitalHong Kong, Hong Kong
Completed
Prince of Wales HospitalShatin, Hong Kong
Completed
Princess Margaret HospitalLai Chi Kok, MISSING, Hong Kong
Completed
Queen Elizabeth Hospital Hong KongKowloon, Hong Kong
Completed
Hospital General de MedellinMedellin, 050015, Colombia
Completed
Fundacio del Caribe para la Investigacio Bio-Medica (BIOS)Barranquilla, Colombia
Completed
Hospital Universitario de San IgnacioSanta Fe de Bogotá, Colombia
Completed
Emergency Institute for Cardiovascular DiseasesBucharest, 22322, Romania
Completed
S.C. CARDIOMED S.R.L. IasiIasi, 700732, Romania
Completed
S.C. CARDIO MED S.R.L.Targu Mures, 540124, Romania
Completed
CMI. Dr. Podoleanu CristianTargu Mures, TBC, Romania
Completed
Sp. Judetean de Urgenta Dr. Constantin Opris Baia MareBaia Mare, 430031, Romania
Completed
Emergency Institute for Cardiovascular DiseasesBucuresti, 022322, Romania
Withdrawn
Prof.Dr.Th. Burghele Clinical HospitalBucuresti, 50659, Romania
Completed
S.C. Sal Med SRLPitesti, TBC, Romania
Completed
Sf. Ap. Andrei Emergency Clinical County Hospital GalatiGalati, 800578, Romania
Withdrawn
Clinical Emergency County HospitalCluj-Napoca, 400006, Romania
Completed
Spitalul Clinic de Urgenta “Sf. Pantelimon”Bucuresti, Romania
Completed
Emergency Clinical County Hospital CraiovaCraiova Dolj, 200642, Romania
Withdrawn
Spitalul Clinic de Urgenta Sf. IoanBucharest, 042122, Romania
Completed
S.C Thera Card S.R.LBrasov, Romania
Completed
Spitalul Clinic Municipal de Urgenta "Timisoara"Timisoara, 300040, Romania
Completed
Timisoara Institute of Cardiovascular DiseasesTimisoara, 300310, Romania
Completed
Municipal Clinical Emergency Hospital of TimisoaraTimisoara, 300079, Romania
Completed
Spitatul Universitar de Urgenta BucarestiBucharest, 50098, Romania
Withdrawn
Sf Pantelimon Emergency County Hospital FocsaniFocsani, 620034, Romania
Completed
Emergency County Hospital, BrailaBraila, 810318, Romania
Completed
Cardiology PartnersWellington, 33449, United States
Completed
St. Cloud HospitalSt. Cloud, 56303, United States
Completed
KMH Cardiology Clinics Inc.Mississauga, L5K 2L3, Canada
Completed
North York Diagnostic and Cardiac CentreNorth York, M6B 3H7, Canada
Completed
Regionshospitalet RandersRanders, 8930, Denmark
Completed
Liepaja Regional HospitalLiepaja, LV-3414, Latvia
Completed
1st Riga Clinical HospitalRiga, LV-1001, Latvia
Completed
GK NeiroklinikaRiga, LV-1024, Latvia
Completed
Daugavpils Regional HospitalDaugavpils, LV-5417, Latvia
Completed
Jelgava Outpatient ClinicJelgava, LV-3001, Latvia
Withdrawn
Tallahassee Research InstituteTallahassee, 32308, United States
Completed
Doylestown Cardiology Associates-VIAADoylestown, 18901, United States
Completed
Yinchuan No.1 People's HospitalYinchuan, 750001, China
Completed
South Denver Cardiology Associates, PCLittleton, 80120, United States
Completed
Henry Ford Health SystemDetroit, 48202, United States
Completed
Kettering Health NetworkKettering, 45429, United States
Completed
Harbor - UCLA Medical CenterTorrance, 90502, United States
Withdrawn
Veterans Benefits Administration | Minneapolis VA Medical Center - Cardiology DepartmentMinneapolis, 55417, United States
Completed
Shanxi Provincial People's HospitalXi `an, 710068, China
Completed
Nanfang Hospital, Southern Medical UniversityGuangzhou, 510515, China
Withdrawn
Torbay HospitalTorbay, TQ2 7AA, United Kingdom
Withdrawn
The First Affiliated Hospital of GZ Medical UniversityGuangzhou, 510120, China
Completed
Zhongda Hospital Southeast UniversityNanjing, 210009, China
Completed
The Third Xiangya Hospital of Central South UniversityChangsha, 410013, China
Completed
Hainan Provincial People's HospitalHaikou, 570311, China
Completed
Tianjin People's HospitalTianjin, 300000, China
Completed
SUN YAT-SEN MEMORIAL HOSP. SUN YAT-SEN UNIV.Guangzhou, 510120, China
Completed
Hainan Third People's Hospital (Province Nongken Sanya Hopt)Sanya, 572000, China
Withdrawn
ZheJiang Provincial People's HospitalHangzhou, 310014, China
Completed
Hunan Provincial People's HospitalChangsha, 410005, China
Completed
Changsha Central HospitalChangsha, 410004, China
Completed
1st Affiliated Hospital of College Medicine, Zhejiang Univ.Hangzhou, 310003, China
Completed
Blackpool Victoria HospitalBlackpool, FY3 8NR, United Kingdom
Completed
Poole Hospital NHS TrustPoole, BH15 2JB, United Kingdom
Completed
North Hampshire HospitalBasingstoke, RG24 9NA, United Kingdom
Completed
Consultorio de Medicina Especializada del Sector PrivadoGuadalajara, 44657, Mexico
Completed
Hospital General de AcapulcoAcapulco, 39910, Mexico
Completed
R.I.A.C Naha City HospitalNaha, 902-8511, Japan
Completed
Funabashi Municipal Medical CenterFunabashi, 273-8588, Japan
Completed
Xinxiang Central HospitalXinxiang, 453000, China
Completed
Hospital San Vicente FundaciónMedellin, 050010, Colombia
Withdrawn
Clinica Colsanitas S.A, Sede Clinica Universitaria ColombiaBogotá, TBC, Colombia
Completed
Sagamihara Kyodo HospitalSagamihara, 252-5188, Japan
Completed
JA Toride Medical CenterToride, 302-0022, Japan
Completed
Iwate Prefectural Central HospitalMorioka, 020-0066, Japan
Completed
Kagawa Prefectural Central HospitalTakamatsu, 760-8557, Japan
Withdrawn
Hokkaido University HospitalSapporo, 060-8648, Japan
Withdrawn
Fukuoka University HospitalFukuoka, 814-0180, Japan
Completed
Osaka Police Hospital | Clinical Research and Trial CenterOsaka, 543-0035, Japan
Completed
Hospital da Senhora da Oliveira | Clinical Research DepartmentGuimaraes, 4835-044, Portugal
Completed
Jinan Central HospitalJinan, 250013, China
Completed
The First Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, 510080, China
Completed
The First Affiliated Hospital of Jinan UniversityGuangzhou, 510630, China
Withdrawn
Hospital Reina SofíaCórdoba, 14004, Spain
Completed
Public Central Hospital of Matto Ishikawa | Clinical Trial Management OfficeHakusan, 924-8588, Japan
Completed
Ogaki Municipal HospitalOgaki, 503-8502, Japan
Withdrawn
Matsuyama Red Cross HospitalMatsuyama, 790-8524, Japan
Completed
National Hospital Organization Tokyo Medical CenterMeguro-ku, 152-8902, Japan
Completed
Kumamoto University HospitalKumamoto, 860-8556, Japan
Completed
Kawaguchi Cardiovascular and Respiratory HospitalKawaguchi, 333-0842, Japan
Completed
Toyama University HospitalToyama, 930-0194, Japan
Completed
Maastricht UMCMAASTRICHT, 6229 HX, Netherlands
Completed
Maxima Medisch Centrum, locatie VeldhovenVELDHOVEN, 5504 DB, Netherlands
Completed
Ziekenhuis St. JansdalHARDERWIJK, 3844 DG, Netherlands
Completed
Universitair Medisch Centrum GroningenGRONINGEN, 9700 RB, Netherlands
Completed
Hospital da Luz - SetubalSetubal, 2900-722, Portugal
Withdrawn
Instituto Brasil de Pesquisa Clínica S/A - IBPClinRio de Janeiro, 20241-180, Brazil
Completed
Hospital do Coração do BrasilBrasilia, 70100-000, Brazil
Completed
Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research CenterPorto Alegre, 90035-007, Brazil
Completed
Centro de Pesquisa Clinica do Coração | Aracaju, BrasilAracaju, 49055-530, Brazil
Completed
Instituto do Coração de Marilia | Marilia, BrasilMarília, 17515-000, Brazil
Completed
MK Consultoria Médico Científica Ltda/Angiocor BlumenauBlumenau, 89020-430, Brazil
Completed
IMC - Instituto de Moléstias Cardiovasculares TatuiTatui, 18270-170, Brazil
Completed
FZ Pesquisa e Servicos em Cardiologia | Porto Alegre, BrazilPorto Alegre, 91350-200, Brazil
Completed
Fundação Universidade de Caxias do SulCaxias do Sul, 95070-560, Brazil
Completed
Santa Casa de Misericórdia de VotuporangaVotuporanga, TBC, Brazil
Completed
Eurolatino Pesquisas Medicas | Uberlandia, MGMinas Gerais, 38400-368, Brazil
Completed
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao LucasCampinas, 13060-803, Brazil
Completed
Quanta Diagnostico Por Imagem | Research and Innovation DepartmentCuritiba, 80045-170, Brazil
Completed
Turun yliopistollinen keskussairaalaTurku, 20520, Finland
Completed
Tampereen yliopistollinen sairaala, keskussairaalaTampere, 33520, Finland
Completed
Max Super Speciality Hospital, SaketNew Delhi, 110017, India
Completed
Budai Irgalmasrendi KorhazBudapest, 1023, Hungary
Withdrawn
Dombovari Szent Lukacs KorhazDombovar, 7200, Hungary
Completed
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6725, Hungary
Completed
Budapesti Uzsoki Utcai KorhazBudapest, 1145, Hungary
Completed
Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi OktatokorhazMiskolc, 3526, Hungary
Completed
Bugat Pal KorhazGyongyos, 3200, Hungary
Completed
Guizhou Provincial People’s HospitalGuiyang, 550002, China
Completed
Kitasato University HospitalSagamihara, 252-0375, Japan
Completed
Nelson HospitalNelson, 7042, New Zealand
Completed
P. Stradins Clinical University HospitalRiga, LV-1002, Latvia
Completed
Mobile Heart Specialists, PCMobile, 36608, United States
Completed
Advocate Good Samaritan HospitalDowners Grove, 60515, United States
Completed
University of North CarolinaChapel Hill, 27599, United States
Completed
Cardiovascular Associates Research, LLCCovington, 70433, United States
Completed
University of Texas Medical Branch at GalvestonGalveston, 77555-0553, United States
Completed
Texas Health Physicians Group - Fort WorthFort Worth, 76107, United States
Completed
Southern Clinical Research, LLCZachary, 70791, United States
Completed
Harry S. Truman Memorial Veterans HospitalColumbia, 65201, United States
Withdrawn
Hunter Holmes McGuire Veterans Affairs Medical CenterRichmond, 23249, United States
Completed
Suburban HospitalBethesda, 20814, United States
Completed
Heart Clinic of HammondHammond, 70403, United States
Completed
South Oklahoma Heart Research, LLCOklahoma City, 73135, United States
Completed
Nova Clinical Research | Brandenton, FLBrandenton, 34209, United States
Completed
University of Arizona Health Science CenterTucson, 85724, United States
Completed
Trident Cardiology Associates, PALadson, 29456, United States
Completed
Reid Physician Associates | Cardiology DepartmentRichmond, 47374, United States
Completed
Texas Health Physicians Group - DallasDallas, 75231, United States
Completed
Hudson Valley Cardiovascular Practice, PCPoughkeepsie, 12601, United States
Completed
Heart Clinic ArkansasLittle Rock, 72205, United States
Completed
ULSM - Hospital Pedro HispanoMatosinhos, 4464-513, Portugal
Completed
Flinders Medical CentreBedford Park, 5042, Australia
Completed
Advara HeartCare RingwoodBundoora, 3083, Australia
Completed
Advara HeartCare LeabrookLeabrook, 5068, Australia
Completed
The Wesley HospitalAuchenflower, 4066, Australia
Completed
The Prince Charles HospitalChermside, 4032, Australia
Completed
John Hunter HospitalNEW LAMBTON HEIGHTS, 2305, Australia
Completed
Salem VA Medical CenterSalem, 24153, United States
Completed
Houston Heart & Vascular AssociatesHumble, 77338, United States
Withdrawn
Gosford HospitalGosford, 2250, Australia
Completed
Royal Brisbane and Women's HospitalHerston, 4006, Australia
Completed
Edward Hospital-Main CampusNaperville, 60540, United States
Completed
UC Irvine Medical CenterOrange, 92868, United States
Completed
Cardiovascular & Vein Center of Florida | Bradenton, FLBradenton, 34209, United States
Completed
Malcom Randall VA Medical CtrGainesville, 32608, United States
Completed
Division of Cardiovascular Research at Peconic Bay Med CtrRiverhead, 11901, United States
Completed
Laurelton Heart SpecialistsRosedale, 11422, United States
Completed
Sanford USD Medical CenterSioux Falls, 57105, United States
Withdrawn
Gold Coast University HospitalSouthport, 4215, Australia
Completed
Cardiovascular Specialists of Central Maryland, PABaltimore, 21205, United States
Completed
LifeSpring Research Foundation, LLCMiami, 33130, United States
Completed
Mercy Health - St. Elizabeth Youngstown HospitalYoungstown, 44501, United States
Completed
John Hopkins Outpatient CenterBaltimore, 21287, United States
Withdrawn
Royal Prince Alfred HospitalCamperdown, 2050, Australia
Completed
Maine Medical Partners-Maine Health CardiologyScarborough, 04074, United States
Completed
Sentara Norfolk General HospitalNorfolk, 23507, United States
Completed
Stony Brook University Medical CenterStony Brook, 11794, United States
Completed
Imed19-privatWien, 1190, Austria
Completed
Brampton Clinical TrialsBrampton, L6Z 4N5, Canada
Completed
Hospital Prof. Dr. Fernando FonsecaAmadora, 2720-276, Portugal
Completed
ULSG – Unidade Local de Saude da GuardaGuarda, 6300-659, Portugal
Completed
Midwest Cardiovascular Research and Education FoundationElkhart, 46514, United States
Withdrawn
Inova Medical Group - Mt. VernonAlexandria, 22306, United States
Completed
St. Luke’s Mid America Heart InstituteKansas City, 64111, United States
Completed
Monument Health Clinical ResearchRapid City, 57701, United States
Completed
P. Stradins Clinical University HospitalRiga, LV-1002, Latvia
Completed
Medicus MFC Inc.Toronto, M4P 1E4, Canada
Completed
Aurora Saint Luke's Medical CenterMilwaukee, 53215, United States
Completed
M Health FairviewMaplewood, 55109, United States
Completed
Captain James A. Lovell Federal Health Care CenterNorth Chicago, 60064, United States
Completed
North Dallas Research Associate | McKinney, TXMcKinney, 75069-1780, United States
Completed
California Heart SpecialistsCypress, 90630, United States
Completed
Kent HospitalWarwick, 02886, United States
Completed
Kansas Nephrology Research Institute, LLCWichita, 67214, United States
Completed
South Texas Cardiovascular Consultants, PLLCSan Antonio, 78201, United States
Completed
South Texas Cardiovascular Consultants, PLLC / Kerrville, TXKerrville, 78028, United States
Completed
Kernodle Clinic West, Private Diagnostic Clinic PLLCBurlington, 27215, United States
Completed
ClinRx Research, LLCPlano, 75024, United States
Completed
Rama Research LLC | Marion, OHMarion, 43302-6774, United States
Completed
Atlanta Heart Specialists, LLCTucker, 30084, United States
Completed
NorthBay Clinical Research, LLC | Santa Rosa, CASanta Rosa, 95405, United States
Withdrawn
Univerzitna nemocnica Bratislava, Nemocnica RuzinovBratislava, 826 06, Slovakia
Completed
Deenanath Mangeshkar HospitalPune, 411004, India
Completed
KEM hospitalPune, 411011, India
Completed
William S. Middleton Memorial Veterans HospitalMadison, 53705, United States
Completed
Western Michigan University School of MedicineKalamazoo, 49007, United States
Withdrawn
San Diego VA Medical CenterSan Diego, 92161, United States
Completed
Aspirus Research InstituteWausau, 54401, United States
Completed
HUS Jorvin sairaalaEspoo, 02740, Finland
Completed
Affidea Praha s.r.oPraha 11 - Chodov, 148 00, Czechia
Completed
University General Hospital of PatraPatra, 26504, Greece
Completed
HIPPOKRATION General Hospital of AthensAthens, 115 27, Greece
Withdrawn
ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)TILBURG, 5042 AD, Netherlands
Completed
Lt. Col. Luke Weathers, Jr. VA Medical CenterMemphis, 38104, United States
Completed
Gita Rancane - cardiology private practiceVentspils, LV-3601, Latvia
Withdrawn
StudyCor OyJyväskylä, 40620, Finland
Withdrawn
New York Methodist HospitalBrooklyn, 11215, United States
Completed
Clinical Diagnostic CenterKazan, 420101, Russian Federation
Completed
Sverdlovsk Regional Clinical Hospital #1Yekaterinburg, 620102, Russian Federation
Completed
VA Eastern Colorado Health Care SystemAurora, 80045, United States
Withdrawn
Univ. of California San Diego - La JollaLa Jolla, 92037, United States
Completed
Baptist Health PaducahPeducah, 42003, United States
Withdrawn
Seinäjoen keskussairaalaSeinäjoki, 60220, Finland
Completed
Madras Medical Mission InstituteChennai, 600037, India
Withdrawn
Lokmanya Tilak Municipal HospitalMumbai, 400022, India
Completed
Safdarjung HospitalNew Delhi, 110029, India
Withdrawn
The Affiliated Hospital of Inner Mongolia Medical UniversityHohehot, 10050, China
Completed
Blue Coast Research Center, LLCVista, 92083, United States
Completed
Russian Clinical and Research Center of GerontologyMoscow, 129226, Russian Federation
Withdrawn
Clinical Hospital for Emergency Care n.a. N.V.SolovyovYaroslavl, 150003, Russian Federation
Completed
ASST del GardaBrescia, 25085, Italy
Completed
Northwell Health Phys. Partners Cardiology at Valley StreamValley Stream, 11580, United States
Completed
SBI of the Ryazan region “Regional clinical hospital”Ryazan, 390039, Russian Federation
Completed
Baptist Heart -Cardiology - DCT DeptJackson, 39202, United States
Withdrawn
TriHealth Good Samaritan HospitalCincinnati, 45220, United States
Withdrawn
Universitätsherzzentrum Freiburg - Bad KrozingenBad Krozingen, 79189, Germany
Completed
Nanjing Jiangning HospitalNanjing, 211103, China
Completed
Virginia HeartFalls Church, 22042, United States
Completed
Interventional Cardio Medical- DCT DepartmentWest Hills, 91307, United States
Completed
Virginia HeartLeesburg, 20176, United States
Withdrawn
Mount Sinai West HospitalNew York, 10019, United States
Completed
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip FakultesiIstanbul, 34098, Turkey
Completed
Sana-Klinikum Remscheid GmbHRemscheid, 42859, Germany
Completed
Forschungszentrum Ruhr - KliFoCenter GmbHWitten, 58455, Germany
Completed
A.O.U. Mater DominiCatanzaro, 88100, Italy
Withdrawn
WVU Heart & Vascular InstituteMorgantown, 26506, United States
Withdrawn
Baptist Heart -Cardiology - MainJackson, 39202, United States

Primary Outcome

  • Number of cardiovascular deaths and heart failure events
    Composite endpoint. Heart Failure events comprise first and recurrent events
    date_rangeTime Frame:
    Up to 42 months

Secondary Outcome

  • Time to total (first and recurrent) HF events
    date_rangeTime Frame:
    Up to 42 months
  • Improvement in NYHA class from Baseline to Month 12
    date_rangeTime Frame:
    Up to 12 month after start of treatment
  • Change in Total Symptom Score (TSS) from KCCQ.
    Patient Reported Outcomes measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
    date_rangeTime Frame:
    At baseline, Months 6, 9 and 12
  • Time to first occurrence of composite renal endpoint
    Composite renal endpoint: sustained decrease in estimated glomerular filtration rate (eGFR) ≥50% relative to baseline over at least 4 weeks, or sustained eGFR decline to <15ml/min/1.73m2 or initiation of dialysis or renal transplantation.
    date_rangeTime Frame:
    Up to 42 months
  • Time to death from any cause
    date_rangeTime Frame:
    Up to 42 months

Trial design

A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction ≥ 40% (LVEF ≥ 40%)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2