Trial Condition(s):
Chronic heart failure with preserved ejection fraction
Patient-reported outcomes in vericiguat-treated patients with HFpEF (VITALITY-HFpEF)
Bayer Identifier:
19334
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations PACE Cardiology Clinic Newmarket, Canada, L3Y 2P6 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Oakville Cardiologists, Inc. Oakville, Canada, L6K 3W7 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AZ St-Jan Brugge Oostende AV BRUGGE, Belgium, 8000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations AZ Delta ROESELARE, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations H. Hartziekenhuis Mol MOL, Belgium, 2400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Algemeen Stedelijk Ziekenhuis Campus Aalst AALST, Belgium, 9300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital da Luz - Lisboa Lisboa, Portugal, 1500-650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHTS - Hospital Padre Americo Guilhufe, Portugal, 4564-007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Complejo Hospitalario Ntra. Sra. de Valme Sevilla, Spain, 41014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Sanitas La Zarzuela Aravaca, Spain, 28023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario Clinica Puerta de Hierro Majadahonda, Spain, 28222 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Álvaro Cunqueiro Babio - Beade, Spain, 36312 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Sant Joan Despi Moises Broggi Sant Joan Despi, Spain, 08940 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro de Especialidades Médicas Villa Luro, Argentina, C1440CFD | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wake Forest Baptist Health Winston Salem, United States, 27157 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Henry Ford Health System Detroit, United States, 48202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Louis Heart & Vascular, PC St. Louis, United States, 63136 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Interventional Cardiology Medical Group West Hills, United States, 91307 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinique Sante Cardio MC Montreal, Canada, H1T 3Y7 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations London Health Sciences Centre London, Canada, N6A 5A5 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centre De Recherche Du (CRCHUM) - Hotel-Diu Montreal, Canada, H2X 3H8 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SMH Cardiology Clinical Trials Inc Surrey, Canada, V3V 0C6 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CardioVasc HR, Inc. Saint-Jean-sur-Richelieu, Canada, J3A 1J2 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clínica DIM Ramos Mejía, Argentina, B1740ETD | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Heart Centre Singapore Singapore, Singapore, 169609 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Singapore General Hospital Singapore, Singapore, 169608 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinikum der Universität Würzburg Würzburg, Germany, 97078 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinische Forschung Dresden GmbH Dresden, Germany, 01069 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Zentrum für Klinische Studien Südbrandenburg GmbH Elsterwerda, Germany, 04910 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cardiologicum Hamburg - Praxen Wandsbek Hamburg, Germany, 22041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Marienhaus Klinikum Mainz Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Sassari Sassari, Italy, 07100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Grande Ospedale Metropolitano Niguarda Milano, Italy, 20162 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IRCCS Fondazione Policlinico San Matteo Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. di Ferrara Ferrara, Italy, 44124 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASL ROMA 6 Roma, Italy, 00040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT Sveta Marina EAD Varna, Bulgaria, 9010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations NMTH Tzar Boris III Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Specialized Hospital for Actrive Treatm of Card - Pleven Pleven, Bulgaria, 5800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik Pernik, Bulgaria, 2300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Second Medical Center Sofia EOOD Sofia, Bulgaria, 1202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Multiprofile Hospital for Active Treatment Pazardzhik Pazardzhik, Bulgaria, 4400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT "Knyaginya Klementina - Sofia"EAD Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MHAT Dr. Bratan Shukerov AD Smolyan, Bulgaria, 4700 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Multiprofile Hospital for Active Treatment Medline Clinic Plovdiv, Bulgaria, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHLO - Hospital Sao Francisco Xavier Lisboa, Portugal, 1449-005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHUP - Hospital Santo Antonio Porto, Portugal, 4099-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHS - Hospital Sao Bernardo Setubal, Portugal, 2900-446 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital de Cascais Alcabideche, Portugal, 2755-009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Garcia de Orta Almada, Portugal, 2801-951 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) Bad Oeynhausen, Germany, 32545 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cardiology Partners Wellington, United States, 33449 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations East Coast Institute for Research, LLC St. Augustine, United States, 32086 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations WestSide Medical Beverly Hills, United States, 90211 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Capitol Interventional Cardiology Carmichael, United States, 95608 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cardiovascular CRO Ltd. Sudbury, Canada, P3E 5M4 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Michael's Hospital Health Centre Toronto, Canada, M5B 1W8 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Anne Arundel Health System Annapolis, United States, 21401 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Carolina Heart Specialists Lancaster, United States, 29720 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum St. Pölten St. Pölten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bryan Heart Lincoln, United States, 68506 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fox Valley Clinical Research Center, LLC Aurora, United States, 60506 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Penrose-St. Francis Health Services Colorado Springs, United States, 80923 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro de Investigaciones Clinicas del Litoral Santa Fe, Argentina, S3000FWO | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sanatorio Parque S.A. Rosario, Argentina, S2000DSV | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Inst. de Cardiología de Corrientes Juana Francisca Cabral Corrientes, Argentina, 3400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Instituto de Investigaciones Clínicas San Nicolás San Nicolás, Argentina, B2900DMH | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IPS Centro Cientifico Asistencial S.A.S Barranquilla, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Caja de Compensación Familiar CAFAM Bogotá, Colombia, 0 | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fundación Cardiovascular de Colombia Floridablanca, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital General de Medellin Medellin, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Kliniczny Przemienienia Panskiego Poznan, Poland, 61-848 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ Wroclaw, Poland, 50-981 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin, Poland, 70-240 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CLINICAL MEDICAL RESEARCH Sp. z o. o. Katowice, Poland, 40-156 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Bydgoszcz, Poland, 85-681 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej Wroclaw, Poland, 54-049 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations SPZOZ Centralny Szpital Kliniczny UM w Lodzi Lodz, Poland, 92-213 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uniwersyteckie Centrum Kliniczne Warszawskiego UM Warszawa, Poland, 02-097 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, Poland, 15-276 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Zentrum f. klinische Studien Dr. Hanusch GmbH Wien, Austria, 1060 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ordensklinikum Linz GmbH Elisabethinen Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinik Floridsdorf - Krankenhaus Nord Wien, Austria, 1210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz Budapest, Hungary | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz Budapest, Hungary, 1134 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft. Nyiregyhaza, Hungary, 4400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kanizsai Dorottya Hospital Nagykanizsa, Hungary, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Budai Irgalmasrendi Korhaz Budapest, Hungary, 1027 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Pharma4Trial Kft. Gyongyos, Hungary, 3200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations G. GENNIMATAS General State Hospital of Athens Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA Nea Ionia / Athens, Greece, 142 33 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations KAT General Hospital of Athens Kifisia / Athens, Greece, 14561 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University General Hospital of Larissa Larissa, Greece, 41100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations “AHEPA” University General Hospital of Thessaloniki Thessaloniki, Greece, 54636 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Glacier View Research Institute Kalispell, United States, 59901 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krankenhaus St. Josef Braunau Braunau, Austria, 5280 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro de Investigaciones Clínicas Buenos Aires, Argentina, C1425DES | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shamir Medical Center (Assaf Harofeh) Zrifin, Israel, 7030000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kaplan Medical Center Rehovot, Israel, 7610001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hillel Yaffe Medical Center Hadera, Israel, 3810101 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clalit Health Services through HaEmek Medical Center Afula, Israel, 1834111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Baruch Padeh Medical Center, Poriya Tiberias, Israel, 1528001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Health Corporation of the Ziv Medical Center (R.A.) Zefat, Israel, 1311001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Capital Area Research, LLC Camp Hill, United States, 17011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Research Integrity, LLC Owensboro, United States, 42303 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Reid Health Richmond, United States, 47374 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cardiology Associates Research Company Daytona Beach, United States, 32117 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Southwest Florida Research Naples, United States, 34102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fukui Prefectural Hospital Fukui, Japan, 910-8526 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Minamino Cardiovascular Hospital Hachioji, Japan, 192-0918 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Iwate Prefectural Central Hospital Morioka, Japan, 020-0066 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toho University Omori Medical Center Ota-ku, Japan, 143-8541 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Higashi Takarazuka Satoh Hospital Takarazuka, Japan, 665-0873 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Hamada Medical Center Hamada, Japan, 697-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toyama Prefectural Central Hospital Toyama, Japan, 930-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Alberta Edmonton, Canada, T6G 2B7 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cardiology Associates of Fairfield County, PC Trumbull, United States, 06611 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Heart Clinic of Hammond Hammond, United States, 70403 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Stern Cardiovascular Center Germantown, United States, 38138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Far Eastern Memorial Hospital New Taipei City, Taiwan, China, 220 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sci-Res. Institute of Complex Cardiovascular Disorders Kemerovo, Russia, 650002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Research center of therapy and prophylactic medicine Moscow, Russia, 101990 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations City hospital #15 St. Petersburg, Russia, 198205 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Moscow State University n.a. M.V. Lomonosov Moscow, Russia, 119192 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centro de Medicina Integral e Investigacion Clínica CABA, Argentina, C1426EGR | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cheng Hsin General Hospital Taipei, Taiwan, China, 112 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cardiovascular and Vein Center of Florida Bradenton, United States, 34209 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Durban Medical Centre Durban, South Africa, 4067 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations TREAD Research cc Cape Town, South Africa, 7500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tiervlei Trial Centre Cape Town, South Africa, 7531 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nash Ranjith Research Centre Merebank, South Africa, 4052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vergelegen Medi-Clinic Somerset West, South Africa, 7130 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Trial Systems Pretoria, South Africa | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mediservis del Tolima IPS S.A.S Ibague, Colombia | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Cardiology Associates Of South Florida PA Boynton Beach, United States, 33472 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sarawak Heart Centre Sarawak, Malaysia, 94300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Institute Jantung Negara Kuala Lumpur, Malaysia, 50400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Raja Perempuan Zainab II Kelantan, Malaysia, 15200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano, Italy, 20089 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Advocate Condell Medical Center Libertyville, United States, 60048 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Takatsuki Red Cross Hospital Takatsuki, Japan, 569-1096 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-0042 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokyo Women's Medical University Hospital Shinjuku-ku, Japan, 162-8666 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Kanazawa Medical Center Kanazawa, Japan, 920-8650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Okayama Rosai Hospital Okayama, Japan, 702-8055 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka Medical College Hospital Takatsuki, Japan, 569-8686 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Corporation Lane Research Center Virginia Beach, United States, 23462 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations LifeSpring Research Foundation, LLC Miami, United States, 33130 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Matsuda Cardiovascular clinic Sapporo, Japan, 003-0026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hirakata kohsai Hospital Hirakata, Japan, 573-0153 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Kobe Medical Center Kobe, Japan, 654-0155 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seikeikai New Tokyo Heart Clinic Matsudo, Japan, 271-0077 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uji-Tokushukai Medical Center Uji, Japan, 611-0041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Steel Memorial Yawata Hospital Kitakyushu, Japan, 805-8508 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Advancement Center, PLLC San Antonio, United States, 78212-4740 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations City Pokrovskaya Hospital St. Petersburg, Russia, 199106 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Samara Regional Clinical Cardiology Dispensary n.a. Polyakov Samara, Russia, 443070 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Riser Medical Associates Picayune, United States, 39466 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Iwakuni Clinical Center Iwakuni, Japan, 740-8510 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Primary Outcome
- Change in KCCQ physical limitation score from baseline to week 24The 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.Timeframe: From baseline to Week 24
Secondary Outcome
- Change in the Six-minute walk test (6MWT) from baseline to week 246MWT 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.Timeframe: From baseline to Week 24
Additional Information
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