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