check_circleStudy Completed

Chronic heart failure with preserved ejection fraction

Patient-reported outcomes in vericiguat-treated patients with HFpEF

Trial purpose

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

Key Participants Requirements

Sex

All

Age

45 - N/A
  • - Previous diagnosis of chronic heart failure (HF)
    - HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or intravenous (IV) diuretic treatment for HF without hospitalization.
    - N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP
    ≥600 or BNP ≥200 pg/mL in atrial fibrillation within 30 days prior to randomization
    - Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility with no interim event signaling potential deterioration in ejection fraction)
     -- Left ventricular ejection fraction (LVEF) ≥45%
    and
     -- Structural changes indicated by at least one of the following parameters:
     --- Left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m*2 in male and ≥95 g/m*2 in female),
    or
     --- Left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index ≥29 ml/m*2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm*2, or LA diameter >40 mm in male and >38 mm in female patients)
    - NYHA class II or III at randomization
  • - Clinical instability at randomization, defined by
     -- Any IV treatment within 24h prior to randomization, and/or
     -- SBP ≥160 mmHg
     -- SBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension
     -- Resting heart rate (HR) <50 or ≥100 beats per minute (bpm)
    - Use of IV inotropes at any time between qualifying HF event and randomization
    - Previous diagnosis of reduced ejection fraction (EF) (EF <40%)
    - Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or pericardial disease
    - Primary valvular heart disease requiring surgery or intervention, or within 3 months after valvular surgery or intervention, or active endocarditis
    - Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 60 days prior to randomization, or indication for Percutaneous coronary intervention or CABG at the time of
    randomization
    - Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days prior to randomization
    - Complex congenital heart disease
    - Non-cardiac comorbidity (any of the following)
     -- Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m*2 calculated by Modification of Diet in Renal Disease formula
     -- Hepatic insufficiency classified as Child-Pugh B or C
     -- Morbid obesity with a body mass index >45 kg/m*2
     -- Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment
     -- Requires continuous home oxygen for severe pulmonary disease or
    has interstitial lung disease
     -- Patients with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients
    - Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator

Trial summary

Enrollment Goal
789
Trial Dates
June 2018 - November 2019
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Vericiguat (BAY1021189)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
PACE Cardiology ClinicNewmarket, L3Y 2P6, Canada
Completed
Oakville Cardiologists, Inc.Oakville, L6K 3W7, Canada
Completed
UZ AntwerpenEDEGEM, 2650, Belgium
Completed
AZ St-Jan Brugge Oostende AVBRUGGE, 8000, Belgium
Withdrawn
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
AZ DeltaROESELARE, 8800, Belgium
Completed
H. Hartziekenhuis MolMOL, 2400, Belgium
Withdrawn
ZNA MiddelheimANTWERPEN, 2020, Belgium
Completed
Algemeen Stedelijk Ziekenhuis Campus AalstAALST, 9300, Belgium
Completed
Hospital da Luz - LisboaLisboa, 1500-650, Portugal
Completed
CHTS - Hospital Padre AmericoGuilhufe, 4564-007, Portugal
Completed
Complejo Hospitalario Ntra. Sra. de ValmeSevilla, 41014, Spain
Completed
Hospital Virgen de la VictoriaMálaga, 29010, Spain
Completed
Hospital Sanitas La ZarzuelaAravaca, 28023, Spain
Completed
Hospital Universitario Clinica Puerta de HierroMajadahonda, 28222, Spain
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Ciutat Sanitària i Universitària de BellvitgeL'Hospitalet de Llobregat, 08907, Spain
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Withdrawn
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Hospital Álvaro CunqueiroBabio - Beade, 36312, Spain
Completed
Hospital Sant Joan Despi Moises BroggiSant Joan Despi, 08940, Spain
Completed
Centro de Especialidades MédicasVilla Luro, C1440CFD, Argentina
Completed
Wake Forest Baptist HealthWinston Salem, 27157, United States
Withdrawn
Sutter Heart & Vascular InstituteSacramento, 95816, United States
Completed
Henry Ford Health SystemDetroit, 48202, United States
Completed
St. Louis Heart & Vascular, PCSt. Louis, 63136, United States
Completed
Interventional Cardiology Medical GroupWest Hills, 91307, United States
Withdrawn
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
Clinique Sante Cardio MCMontreal, H1T 3Y7, Canada
Completed
London Health Sciences CentreLondon, N6A 5A5, Canada
Completed
Centre De Recherche Du (CRCHUM) - Hotel-DiuMontreal, H2X 3H8, Canada
Completed
SMH Cardiology Clinical Trials IncSurrey, V3V 0C6, Canada
Completed
CardioVasc HR, Inc.Saint-Jean-sur-Richelieu, J3A 1J2, Canada
Completed
Clínica DIMRamos Mejía, B1740ETD, Argentina
Completed
National Heart Centre SingaporeSingapore, 169609, Singapore
Completed
Singapore General HospitalSingapore, 169608, Singapore
Completed
Klinikum der Universität WürzburgWürzburg, 97078, Germany
Completed
Kliniken Maria Hilf GmbHMönchengladbach, 41063, Germany
Completed
Klinische Forschung Dresden GmbHDresden, 01069, Germany
Completed
Zentrum für Klinische Studien Südbrandenburg GmbHElsterwerda, 04910, Germany
Completed
Cardiologicum Hamburg - Praxen WandsbekHamburg, 22041, Germany
Completed
Marienhaus Klinikum MainzMainz, 55131, Germany
Withdrawn
Bethanien KrankenhausFrankfurt, 60389, Germany
Withdrawn
University of Iowa Hospitals & ClinicsIowa City, 52242-1089, United States
Completed
ASST Papa Giovanni XXIIIBergamo, 24127, Italy
Withdrawn
AUSL Toscana Sud-EstArezzo, 52044, Italy
Completed
ASST Spedali Civili di BresciaBrescia, 25123, Italy
Completed
A.O.U. di SassariSassari, 07100, Italy
Completed
ASST Grande Ospedale Metropolitano NiguardaMilano, 20162, Italy
Completed
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
IRCCS Fondazione Policlinico San MatteoPavia, 27100, Italy
Completed
A.O.U. di FerraraFerrara, 44124, Italy
Completed
ASL ROMA 6Roma, 00040, Italy
Completed
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Completed
NMTH Tzar Boris IIISofia, 1233, Bulgaria
Completed
Specialized Hospital for Actrive Treatm of Card - PlevenPleven, 5800, Bulgaria
Completed
Spec Hosp for Active Treatm in Cardiology Sv Georgi PernikPernik, 2300, Bulgaria
Completed
Second Medical Center Sofia EOODSofia, 1202, Bulgaria
Completed
Multiprofile Hospital for Active Treatment PazardzhikPazardzhik, 4400, Bulgaria
Completed
MHAT "Knyaginya Klementina - Sofia"EADSofia, 1233, Bulgaria
Completed
MHAT Dr. Bratan Shukerov ADSmolyan, 4700, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Medline ClinicPlovdiv, 4000, Bulgaria
Completed
CHLO - Hospital Sao Francisco XavierLisboa, 1449-005, Portugal
Completed
CHUP - Hospital Santo AntonioPorto, 4099-001, Portugal
Completed
CHS - Hospital Sao BernardoSetubal, 2900-446, Portugal
Completed
Hospital de CascaisAlcabideche, 2755-009, Portugal
Completed
Hospital Garcia de OrtaAlmada, 2801-951, Portugal
Completed
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)Bad Oeynhausen, 32545, Germany
Completed
Cardiology PartnersWellington, 33449, United States
Completed
East Coast Institute for Research, LLCSt. Augustine, 32086, United States
Withdrawn
East Coast Institute for Research, LLCJacksonville, 32216, United States
Withdrawn
Banner – University Medical Center TucsonTucson, 85724, United States
Withdrawn
University of Mississippi Medical CenterJackson, 39216, United States
Completed
WestSide MedicalBeverly Hills, 90211, United States
Completed
Capitol Interventional CardiologyCarmichael, 95608, United States
Completed
Cardiovascular CRO Ltd.Sudbury, P3E 5M4, Canada
Completed
St. Michael's Hospital Health CentreToronto, M5B 1W8, Canada
Completed
Anne Arundel Health SystemAnnapolis, 21401, United States
Completed
Carolina Heart SpecialistsLancaster, 29720, United States
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Universitätsklinikum St. PöltenSt. Pölten, 3100, Austria
Terminated
Bryan HeartLincoln, 68506, United States
Completed
Fox Valley Clinical Research Center, LLCAurora, 60506, United States
Completed
Penrose-St. Francis Health ServicesColorado Springs, 80923, United States
Completed
Centro de Investigaciones Clinicas del LitoralSanta Fe, S3000FWO, Argentina
Completed
Sanatorio Parque S.A.Rosario, S2000DSV, Argentina
Completed
Inst. de Cardiología de Corrientes Juana Francisca CabralCorrientes, 3400, Argentina
Completed
Instituto de Investigaciones Clínicas San NicolásSan Nicolás, B2900DMH, Argentina
Completed
IPS Centro Cientifico Asistencial S.A.SBarranquilla, Colombia
Terminated
Caja de Compensación Familiar CAFAMBogotá, Colombia
Withdrawn
Rodrigo Botero S.A.SMedellín, Colombia
Withdrawn
Fundación Cardiomet CEQUIN Eje CafeteroArmenia, Colombia
Completed
Fundación Cardiovascular de ColombiaFloridablanca, Colombia
Withdrawn
CICLAMMedellín, Colombia
Withdrawn
Fundacion Cardiovascular Santa MariaMedellín, Colombia
Completed
Hospital General de MedellinMedellin, Colombia
Completed
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Withdrawn
Mackay Memorial Hospital - Hsinchu BranchHsinchu City, 300, Taiwan
Completed
Szpital Kliniczny Przemienienia PanskiegoPoznan, 61-848, Poland
Completed
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZWroclaw, 50-981, Poland
Completed
Twoja Przychodnia - Szczecinskie Centrum MedyczneSzczecin, 70-240, Poland
Completed
CLINICAL MEDICAL RESEARCH Sp. z o. o.Katowice, 40-156, Poland
Completed
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZBydgoszcz, 85-681, Poland
Completed
Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny RatunkowejWroclaw, 54-049, Poland
Completed
SPZOZ Centralny Szpital Kliniczny UM w LodziLodz, 92-213, Poland
Withdrawn
SP Szpital Kliniczny nr 7 Slaskiego Uniwersytetu MedycznegoKatowice, 40-635, Poland
Completed
Uniwersyteckie Centrum Kliniczne Warszawskiego UMWarszawa, 02-097, Poland
Completed
Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, 15-276, Poland
Withdrawn
Grace Research, LLCBossier City, 71111, United States
Completed
Zentrum f. klinische Studien Dr. Hanusch GmbHWien, 1060, Austria
Withdrawn
Klinik Favoriten - Sozialmedizinisches Zentrum SüdWien, 1100, Austria
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Ordensklinikum Linz GmbH ElisabethinenLinz, 4020, Austria
Completed
Klinik Floridsdorf - Krankenhaus NordWien, 1210, Austria
Completed
Magyar Honvedseg Egeszsegugyi Kozpont HonvedkorhazBudapest, Hungary
Completed
Magyar Honvedseg Egeszsegugyi Kozpont HonvedkorhazBudapest, 1134, Hungary
Completed
Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.Nyiregyhaza, 4400, Hungary
Completed
Kanizsai Dorottya HospitalNagykanizsa, 8800, Hungary
Completed
Budai Irgalmasrendi KorhazBudapest, 1027, Hungary
Completed
Pharma4Trial Kft.Gyongyos, 3200, Hungary
Withdrawn
University General Hospital of Athens "ATTIKON"Chaidari, 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
University General Hospital of LarissaLarissa, 41100, Greece
Completed
Hippokration General Hospital of ThessalonikiThessaloniki, 54642, Greece
Completed
“AHEPA” University General Hospital of ThessalonikiThessaloniki, 54636, Greece
Completed
Glacier View Research InstituteKalispell, 59901, United States
Withdrawn
Kent HospitalWarwick, 02886, United States
Completed
Krankenhaus St. Josef BraunauBraunau, 5280, Austria
Completed
Centro de Investigaciones ClínicasBuenos Aires, C1425DES, Argentina
Completed
Shamir Medical Center (Assaf Harofeh)Zrifin, 7030000, Israel
Completed
Kaplan Medical CenterRehovot, 7610001, Israel
Completed
Rambam Health CorporationHaifa, 3109601, Israel
Completed
Hillel Yaffe Medical CenterHadera, 3810101, Israel
Completed
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Completed
Rambam Health CorporationHaifa, 3109601, Israel
Completed
Chaim Sheba Medical CenterRamat Gan, 5262000, Israel
Completed
Clalit Health Services through HaEmek Medical CenterAfula, 1834111, Israel
Completed
The Baruch Padeh Medical Center, PoriyaTiberias, 1528001, Israel
Completed
Health Corporation of the Ziv Medical Center (R.A.)Zefat, 1311001, Israel
Completed
Capital Area Research, LLCCamp Hill, 17011, United States
Completed
Research Integrity, LLCOwensboro, 42303, United States
Withdrawn
Parkway Cardiology Associates, PCOak Ridge, 37830, United States
Completed
Reid HealthRichmond, 47374, United States
Completed
Cardiology Associates Research CompanyDaytona Beach, 32117, United States
Completed
Southwest Florida ResearchNaples, 34102, United States
Withdrawn
Renown Institute for Heart and Vascular HealthReno, 89502, United States
Withdrawn
R.I.A.C Naha City HospitalNaha, 902-8511, Japan
Completed
Fukui Prefectural HospitalFukui, 910-8526, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Minamino Cardiovascular HospitalHachioji, 192-0918, Japan
Withdrawn
Tokyo Heart CenterShinagawa-ku, 141-0001, Japan
Completed
Iwate Prefectural Central HospitalMorioka, 020-0066, Japan
Completed
Toho University Omori Medical CenterOta-ku, 143-8541, Japan
Completed
Higashi Takarazuka Satoh HospitalTakarazuka, 665-0873, Japan
Completed
National Hospital Organization Hamada Medical CenterHamada, 697-8511, Japan
Completed
Toyama Prefectural Central HospitalToyama, 930-8550, Japan
Completed
University of AlbertaEdmonton, T6G 2B7, Canada
Completed
Cardiology Associates of Fairfield County, PCTrumbull, 06611, United States
Completed
Heart Clinic of HammondHammond, 70403, United States
Completed
Stern Cardiovascular CenterGermantown, 38138, United States
Withdrawn
Grace Research, LLCHuntsville, 77340, United States
Completed
National Taiwan University HospitalTaipei, 100, Taiwan
Completed
Far Eastern Memorial HospitalNew Taipei City, 220, Taiwan
Completed
Sci-Res. Institute of Complex Cardiovascular DisordersKemerovo, 650002, Russian Federation
Completed
Research center of therapy and prophylactic medicineMoscow, 101990, Russian Federation
Completed
City hospital #15St. Petersburg, 198205, Russian Federation
Completed
Moscow State University n.a. M.V. LomonosovMoscow, 119192, Russian Federation
Completed
Centro de Medicina Integral e Investigacion ClínicaCABA, C1426EGR, Argentina
Completed
Cheng Hsin General HospitalTaipei, 112, Taiwan
Completed
Cardiovascular and Vein Center of FloridaBradenton, 34209, United States
Withdrawn
Inova Fairfax HospitalFalls Church, 22042, United States
Completed
Durban Medical CentreDurban, 4067, South Africa
Withdrawn
Chris Hani Baragwanath HospitalJohannesburg, 1804, South Africa
Withdrawn
Groote Schuur HospitalCape Town, 7935, South Africa
Completed
TREAD Research ccCape Town, 7500, South Africa
Completed
Tiervlei Trial CentreCape Town, 7531, South Africa
Completed
Nash Ranjith Research CentreMerebank, 4052, South Africa
Completed
Vergelegen Medi-ClinicSomerset West, 7130, South Africa
Completed
Clinical Trial SystemsPretoria, South Africa
Completed
Mediservis del Tolima IPS S.A.SIbague, Colombia
Completed
Cardiology Associates Of South Florida PABoynton Beach, 33472, United States
Completed
Sarawak Heart CentreSarawak, 94300, Malaysia
Completed
Institute Jantung NegaraKuala Lumpur, 50400, Malaysia
Completed
Hospital Raja Perempuan Zainab IIKelantan, 15200, Malaysia
Completed
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.Milano, 20089, Italy
Withdrawn
Allegheny General HospitalPittsburgh, 15212, United States
Completed
Advocate Condell Medical CenterLibertyville, 60048, United States
Withdrawn
PMG Research of DuPage Medical GroupWinfield, 60190, United States
Withdrawn
University of Nebraska Medical CenterOmaha, 68198-9510, United States
Withdrawn
Hudson Valley Urology CenterPoughkeepsie, 12601, United States
Withdrawn
Gleneagles Penang Medical CenterPulau Pinang, 10050, Malaysia
Withdrawn
Hospital Tengku Ampuan AfzanPahang, 25100, Malaysia
Completed
Takatsuki Red Cross HospitalTakatsuki, 569-1096, Japan
Completed
Kishiwada Tokushukai HospitalKishiwada, 596-0042, Japan
Withdrawn
Hyogo Prefectural Amagasaki General Medical CenterAmagasaki, 660-8550, Japan
Completed
Tokyo Women's Medical University HospitalShinjuku-ku, 162-8666, Japan
Completed
National Hospital Organization Kanazawa Medical CenterKanazawa, 920-8650, Japan
Completed
Okayama Rosai HospitalOkayama, 702-8055, Japan
Completed
Osaka Medical College HospitalTakatsuki, 569-8686, Japan
Withdrawn
Hutchinson ClinicHutchinson, 67502-1131, United States
Withdrawn
Phillips Medical ServicesJackson, 39209, United States
Completed
Corporation Lane Research CenterVirginia Beach, 23462, United States
Completed
LifeSpring Research Foundation, LLCMiami, 33130, United States
Withdrawn
M. Reddy CardiologyBaytown, 77521, United States
Completed
Matsuda Cardiovascular clinicSapporo, 003-0026, Japan
Completed
Hirakata kohsai HospitalHirakata, 573-0153, Japan
Completed
National Hospital Organization Kobe Medical CenterKobe, 654-0155, Japan
Completed
Seikeikai New Tokyo Heart ClinicMatsudo, 271-0077, Japan
Withdrawn
Yokohama Minami Kyousai HospitalYokohama, 236-0037, Japan
Completed
Uji-Tokushukai Medical CenterUji, 611-0041, Japan
Withdrawn
Yotsuba Circulation ClinicMatsuyama, 790-0062, Japan
Completed
Steel Memorial Yawata HospitalKitakyushu, 805-8508, Japan
Completed
Clinical Advancement Center, PLLCSan Antonio, 78212-4740, United States
Withdrawn
St.Petersburg City hospital ¿38 n.a. N.A. SemashkoSt. Petersburg, 196601, Russian Federation
Withdrawn
Inova Medical Group Cardiology ProsperityFairfax, 22031, United States
Withdrawn
Inova Medical Group - Mt. VernonAlexandria, 22306, United States
Withdrawn
Salem VA Medical CenterSalem, 24153, United States
Withdrawn
LSU Health Sciences Center New OrleansNew Orleans, 70112, United States
Completed
City Pokrovskaya HospitalSt. Petersburg, 199106, Russian Federation
Completed
Samara Regional Clinical Cardiology Dispensary n.a. PolyakovSamara, 443070, Russian Federation
Completed
Riser Medical AssociatesPicayune, 39466, United States
Completed
National Hospital Organization Iwakuni Clinical CenterIwakuni, 740-8510, Japan
Withdrawn
El Paso Medical Research Institute/ MedResearch, INCEl Paso, 79935, United States

Primary Outcome

  • Change in KCCQ physical limitation score from baseline to week 24
    The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients’ heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status. The data were reported as arithmetic mean.
    date_rangeTime Frame:
    From baseline to Week 24

Secondary Outcome

  • Change in the Six-minute walk test (6MWT) from baseline to week 24
    6MWT was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.
    date_rangeTime Frame:
    From baseline to Week 24

Trial design

A randomized parallel-group, placebo-controlled, double-blind, multi-center trial to evaluate the efficacy and safety of the oral sGC stImulator vericiguat to improve physical functioning in activities of daily living in patients with heart failure and preserved ejection fraction (VITALITY-HFpEF)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3