Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
- Conditions
- Chronic Heart Failure With Preserved Ejection Fraction
- Interventions
- Registration Number
- NCT03547583
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 789
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vericiguat up to 10 mg Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, with sham titration at week 6. Vericiguat up to 15 mg Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets Subjects will receive vericiguat (BAY1021189) for 24 weeks, starting at 2.5 mg once daily at randomization and up-titrated to 5 mg at week 2, to 10 mg at week 4, and to 15 mg at week 6. Placebo Placebo Subject will receive placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.
- Primary Outcome Measures
Name Time Method Change in KCCQ Physical Limitation Score From Baseline to Week 24 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.
- Secondary Outcome Measures
Name Time Method Change in the Six-minute Walk Test (6MWT) From Baseline to Week 24 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.
Trial Locations
- Locations (176)
Capitol Interventional Cardiology
🇺🇸Carmichael, California, United States
Cardiovascular and Vein Center of Florida
🇺🇸Bradenton, Florida, United States
Fox Valley Clinical Research Center, LLC
🇺🇸Aurora, Illinois, United States
Corporation Lane Research Center
🇺🇸Virginia Beach, Virginia, United States
PACE Cardiology Clinic
🇨🇦Newmarket, Ontario, Canada
Tiervlei Trial Centre
🇿🇦Cape Town, Western Cape, South Africa
Nash Ranjith Research Centre
🇿🇦Merebank, Kwazulu-Natal, South Africa
Inst. de Cardiología de Corrientes Juana Francisca Cabral
🇦🇷Corrientes, Argentina
Universitätsklinikum St. Pölten
🇦🇹St. Pölten, Niederösterreich, Austria
MHAT Dr. Bratan Shukerov AD
🇧🇬Smolyan, Bulgaria
Cardiology Associates Research Company
🇺🇸Daytona Beach, Florida, United States
Riser Medical Associates
🇺🇸Picayune, Mississippi, United States
Centro de Especialidades Médicas
🇦🇷Villa Luro, Ciudad Auton. De Buenos Aires, Argentina
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Universitätsklinikum AKH Wien
🇦🇹Wien, Austria
Cardiology Partners
🇺🇸Wellington, Florida, United States
Heart Clinic of Hammond
🇺🇸Hammond, Louisiana, United States
Sanatorio Parque S.A.
🇦🇷Rosario, Santa Fe, Argentina
Klinik Floridsdorf - Krankenhaus Nord
🇦🇹Wien, Austria
V MHAT
🇧🇬Sofia, Bulgaria
Centre De Recherche Du (CRCHUM) - Hotel-Diu
🇨🇦Montreal, Quebec, Canada
Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
🇬🇷Nea Ionia / Athens, Greece
Rambam Health Corporation
🇮🇱Haifa, Israel
Health Corporation of the Ziv Medical Center (R.A.)
🇮🇱Zefat, Israel
ASST Spedali Civili di Brescia
🇮🇹Brescia, Lombardia, Italy
National Hospital Organization Kobe Medical Center
🇯🇵Kobe, Hyogo, Japan
Iwate Prefectural Central Hospital
🇯🇵Morioka, Iwate, Japan
Takatsuki Red Cross Hospital
🇯🇵Takatsuki, Osaka, Japan
Zentrum für Klinische Studien Südbrandenburg GmbH
🇩🇪Elsterwerda, Brandenburg, Germany
Minamino Cardiovascular Hospital
🇯🇵Hachioji, Tokyo, Japan
Toho University Omori Medical Center
🇯🇵Ota-ku, Tokyo, Japan
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Multiprofile Hospital for Active Treatment Medline Clinic
🇧🇬Plovdiv, Bulgaria
St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Pharma4Trial Kft.
🇭🇺Gyongyos, Hungary
Kaplan Medical Center
🇮🇱Rehovot, Israel
A.O.U. di Bologna Policlinico S.Orsola Malpighi
🇮🇹Bologna, Emilia-Romagna, Italy
KAT General Hospital of Athens
🇬🇷Kifisia / Athens, Attica, Greece
Ordensklinikum Linz GmbH Elisabethinen
🇦🇹Linz, Oberösterreich, Austria
Specialized Hospital for Actrive Treatm of Card - Pleven
🇧🇬Pleven, Bulgaria
University General Hospital of Larissa
🇬🇷Larissa, Greece
"AHEPA" University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Hippokration General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Hadassah Hebrew University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
The Baruch Padeh Medical Center, Poria
🇮🇱Tiberias, Israel
Shamir Medical Center (Assaf Harofeh)
🇮🇱Zrifin, Israel
Steel Memorial Yawata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Hospital Garcia de Orta
🇵🇹Almada, Portugal
St. Michael's Hospital Health Centre
🇨🇦Toronto, Ontario, Canada
Stern Cardiovascular Center
🇺🇸Germantown, Tennessee, United States
A.O.U. di Ferrara
🇮🇹Ferrara, Emilia-Romagna, Italy
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Multiprofile Hospital for Active Treatment Pazardzhik
🇧🇬Pazardzhik, Bulgaria
Second Medical Center Sofia EOOD
🇧🇬Sofia, Bulgaria
G. GENNIMATAS General State Hospital of Athens
🇬🇷Athens, Greece
Oakville Cardiologists, Inc.
🇨🇦Oakville, Ontario, Canada
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
🇮🇹Milano, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Lombardia, Italy
Hirakata kohsai Hospital
🇯🇵Hirakata, Osaka, Japan
Fukui Prefectural Hospital
🇯🇵Fukui, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Toyama Prefectural Central Hospital
🇯🇵Toyama, Japan
Hospital Raja Perempuan Zainab II
🇲🇾Kelantan, Malaysia
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
🇵🇱Bydgoszcz, Poland
CHLO - Hospital Sao Francisco Xavier
🇵🇹Lisboa, Portugal
Higashi Takarazuka Satoh Hospital
🇯🇵Takarazuka, Hyogo, Japan
Cardiovascular CRO Ltd.
🇨🇦Sudbury, Ontario, Canada
Hospital General de Medellin
🇨🇴Medellin, Antioquia, Colombia
Caja de Compensación Familiar CAFAM
🇨🇴Bogotá, Distrito Capital De Bogotá, Colombia
Mediservis del Tolima IPS S.A.S
🇨🇴Ibague, Tolima, Colombia
Klinikum der Universität Würzburg
🇩🇪Würzburg, Bayern, Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
🇩🇪Bad Oeynhausen, Nordrhein-Westfalen, Germany
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Sachsen, Germany
Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
🇭🇺Nyiregyhaza, Hungary
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Lombardia, Italy
IRCCS Fondazione Policlinico San Matteo
🇮🇹Pavia, Lombardia, Italy
A.O.U. di Sassari
🇮🇹Sassari, Sardegna, Italy
CardioVasc HR, Inc.
🇨🇦Saint-Jean-sur-Richelieu, Quebec, Canada
IPS Centro Cientifico Asistencial S.A.S
🇨🇴Barranquilla, Atlántico, Colombia
Asl Roma 6
🇮🇹Roma, Lazio, Italy
National Hospital Organization Kanazawa Medical Center
🇯🇵Kanazawa, Ishikawa, Japan
Uji-Tokushukai Medical Center
🇯🇵Uji, Kyoto, Japan
Okayama Rosai Hospital
🇯🇵Okayama, Japan
Sarawak Heart Centre
🇲🇾Sarawak, Malaysia
CLINICAL MEDICAL RESEARCH Sp. z o. o.
🇵🇱Katowice, Poland
Hospital de Cascais
🇵🇹Alcabideche, Lisboa, Portugal
CHTS - Hospital Padre Americo
🇵🇹Guilhufe, Porto, Portugal
CHUP - Hospital Santo Antonio
🇵🇹Porto, Portugal
Samara Regional Clinical Cardiology Dispensary n.a. Polyakov
🇷🇺Samara, Russian Federation
Hospital Sant Joan Despi Moises Broggi
🇪🇸Sant Joan Despi, Barcelona, Spain
National Hospital Organization Hamada Medical Center
🇯🇵Hamada, Shimane, Japan
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
🇵🇱Lodz, Poland
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
🇵🇱Wroclaw, Poland
Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej
🇵🇱Wroclaw, Poland
Singapore General Hospital
🇸🇬Singapore, Singapore
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Moscow State University n.a. M.V. Lomonosov
🇷🇺Moscow, Russian Federation
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Sci-Res. Institute of Complex Cardiovascular Disorders
🇷🇺Kemerovo, Russian Federation
City hospital #15
🇷🇺St. Petersburg, Russian Federation
Vergelegen Medi-Clinic
🇿🇦Somerset West, Western Cape, South Africa
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
CHS - Hospital Sao Bernardo
🇵🇹Setubal, Setúbal, Portugal
Cheng Hsin General Hospital
🇨🇳Taipei, Taiwan
Hospital da Luz - Lisboa
🇵🇹Lisboa, Portugal
Ciutat Sanitària i Universitària de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
St. Louis Heart & Vascular, PC
🇺🇸Saint Louis, Missouri, United States
Interventional Cardiology Medical Group
🇺🇸West Hills, California, United States
Anne Arundel Health System
🇺🇸Annapolis, Maryland, United States
Centro de Investigaciones Clínicas
🇦🇷Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
East Coast Institute for Research, LLC
🇺🇸Saint Augustine, Florida, United States
Cardiology Associates Of South Florida PA
🇺🇸Boynton Beach, Florida, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Glacier View Research Institute
🇺🇸Kalispell, Montana, United States
Cardiology Associates of Fairfield County, PC
🇺🇸Trumbull, Connecticut, United States
LifeSpring Research Foundation, LLC
🇺🇸Miami, Florida, United States
Southwest Florida Research
🇺🇸Naples, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Carolina Heart Specialists
🇺🇸Lancaster, South Carolina, United States
Centro de Investigaciones Clinicas del Litoral
🇦🇷Santa Fe, Argentina
Bryan Heart
🇺🇸Lincoln, Nebraska, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
Clínica DIM
🇦🇷Ramos Mejía, Buenos Aires, Argentina
UZ Antwerpen
🇧🇪Edegem, Belgium
Instituto de Investigaciones Clínicas San Nicolás
🇦🇷San Nicolás, Buenos Aires, Argentina
Centro de Medicina Integral e Investigacion Clínica
🇦🇷Caba, Ciudad Auton. De Buenos Aires, Argentina
Zentrum f. klinische Studien Dr. Hanusch GmbH
🇦🇹Wien, Austria
AZ St-Jan Brugge Oostende AV
🇧🇪Brugge, Belgium
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
🇧🇬Pernik, Bulgaria
Algemeen Stedelijk Ziekenhuis Campus Aalst
🇧🇪Aalst, Belgium
NMTH Tzar Boris III
🇧🇬Sofia, Bulgaria
Kliniken Maria Hilf GmbH
🇩🇪Mönchengladbach, Nordrhein-Westfalen, Germany
SMH Cardiology Clinical Trials Inc
🇨🇦Surrey, British Columbia, Canada
AZ Delta
🇧🇪Roeselare, Belgium
Clinique Sante Cardio MC
🇨🇦Montreal, Quebec, Canada
HaEmek Medical Center
🇮🇱Afula, Israel
Budai Irgalmasrendi Korhaz
🇭🇺Budapest, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
🇭🇺Budapest, Hungary
Fundación Cardiovascular de Colombia
🇨🇴Floridablanca, Colombia
Kanizsai Dorottya Hospital
🇭🇺Nagykanizsa, Hungary
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Seikeikai New Tokyo Heart Clinic
🇯🇵Matsudo, Chiba, Japan
Osaka Medical College Hospital
🇯🇵Takatsuki, Osaka, Japan
Kishiwada Tokushukai Hospital
🇯🇵Kishiwada, Osaka, Japan
National Hospital Organization Iwakuni Clinical Center
🇯🇵Iwakuni, Yamaguchi, Japan
Szpital Kliniczny Przemienienia Panskiego
🇵🇱Poznan, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego UM
🇵🇱Warszawa, Poland
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Hospital del Mar
🇪🇸Barcelona, Spain
Institute Jantung Negara
🇲🇾Kuala Lumpur, Malaysia
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Research center of therapy and prophylactic medicine
🇷🇺Moscow, Russian Federation
TREAD Research cc
🇿🇦Cape Town, Western Cape, South Africa
Clinical Trial Systems
🇿🇦Pretoria, Gauteng, South Africa
City Pokrovskaya Hospital
🇷🇺St. Petersburg, Russian Federation
Durban Medical Centre
🇿🇦Durban, Kwazulu-Natal, South Africa
Hospital Universitario Clinica Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Sanitas La Zarzuela
🇪🇸Aravaca, Madrid, Spain
Hospital Álvaro Cunqueiro
🇪🇸Babio - Beade, Pontevedra, Spain
Complejo Hospitalario Ntra. Sra. de Valme
🇪🇸Sevilla, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
WestSide Medical
🇺🇸Beverly Hills, California, United States
Penrose-St. Francis Health Services
🇺🇸Colorado Springs, Colorado, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
Advocate Condell Medical Center
🇺🇸Libertyville, Illinois, United States
Reid Health
🇺🇸Richmond, Indiana, United States
Krankenhaus St. Josef Braunau
🇦🇹Braunau, Oberösterreich, Austria
H. Hartziekenhuis Mol
🇧🇪MOL, Belgium
London Health Sciences Centre
🇨🇦London, Ontario, Canada
MHAT Sveta Marina EAD
🇧🇬Varna, Bulgaria
Cardiologicum Hamburg - Praxen Wandsbek
🇩🇪Hamburg, Germany
Matsuda Cardiovascular clinic
🇯🇵Sapporo, Hokkaido, Japan