Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF (VITALITY-HFpEF)

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 789
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Corrientes, Argentina, 3400
    • Inst. de Cardiología de Corrientes Juana Francisca Cabral
  • Santa Fe, Argentina, S3000FWO
    • Centro de Investigaciones Clínicas del Litoral
  • Buenos Aires
    • Ramos Mejía, Buenos Aires, Argentina, B1740ETD
      • Clínica DIM
    • San Nicolás, Buenos Aires, Argentina, B2900DMH
      • Instituto de Investigaciones Clinicas San Nicolas
  • Ciudad Auton. De Buenos Aires
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425DES
      • Centro de Investigaciones Clinicas
    • Caba, Ciudad Auton. De Buenos Aires, Argentina, C1426EGR
      • Centro de Medicina Integral e Investigación Clínica
    • Villa Luro, Ciudad Auton. De Buenos Aires, Argentina, C1440CFD
      • Centro de Especialidades Médicas
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DSV
      • Sanatorio Parque S.A.
• Austria
  • Wien, Austria, 1090
    • Universitätsklinikum AKH Wien
  • Wien, Austria, 1060
    • Zentrum f. klinische Studien Dr. Hanusch GmbH
  • Wien, Austria, 1210
    • Klinik Floridsdorf - Krankenhaus Nord
  • Niederösterreich
    • St. Pölten, Niederösterreich, Austria, 3100
      • Universitätsklinikum St. Pölten
  • Oberösterreich
    • Braunau, Oberösterreich, Austria, 5280
      • Krankenhaus St. Josef Braunau
    • Linz, Oberösterreich, Austria, 4020
      • Ordensklinikum Linz GmbH Elisabethinen
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz
• Belgium
  • Aalst, Belgium, 9300
    • Algemeen Stedelijk Ziekenhuis Campus Aalst
  • Brugge, Belgium, 8000
    • AZ St-Jan Brugge Oostende AV
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • MOL, Belgium, 2400
    • H. Hartziekenhuis Mol
  • Roeselare, Belgium, 8800
    • AZ Delta
• Bulgaria
  • Pazardzhik, Bulgaria, 4400
    • Multiprofile Hospital for Active Treatment Pazardzhik
  • Pernik, Bulgaria, 2300
    • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
  • Pleven, Bulgaria, 5800
    • Specialized Hospital for Actrive Treatm of Card - Pleven
  • Plovdiv, Bulgaria, 4000
    • Multiprofile Hospital for Active Treatment Medline Clinic
  • Smolyan, Bulgaria, 4700
    • MHAT Dr. Bratan Shukerov AD
  • Sofia, Bulgaria, 1233
    • NMTH Tzar Boris III
  • Sofia, Bulgaria, 1202
    • Second Medical Center Sofia EOOD
  • Sofia, Bulgaria, 1233
    • V MHAT
  • Varna, Bulgaria, 9010
    • MHAT Sveta Marina EAD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • SMH Cardiology Clinical Trials Inc
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre
    • Newmarket, Ontario, Canada, L3Y 2P6
      • PACE Cardiology Clinic
    • Oakville, Ontario, Canada, L6K 3W7
      • Oakville Cardiologists, Inc.
    • Sudbury, Ontario, Canada, P3E 5M4
      • Cardiovascular CRO Ltd.
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital Health Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 3Y7
      • Clinique Sante Cardio MC
    • Montreal, Quebec, Canada, H2X 3H8
      • Centre De Recherche Du (CRCHUM) - Hotel-Diu
    • Saint-Jean-sur-Richelieu, Quebec, Canada, J3A 1J2
      • CardioVasc HR, Inc.
• Colombia
  • Floridablanca, Colombia
    • Fundacion Cardiovascular de Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Hospital General de Medellin
  • Atlántico
    • Barranquilla, Atlántico, Colombia
      • IPS Centro Científico Asistencial S.A.S
  • Distrito Capital De Bogotá
    • Bogotá, Distrito Capital De Bogotá, Colombia
      • Caja de Compensación Familiar CAFAM
  • Tolima
    • Ibague, Tolima, Colombia
      • Mediservis del Tolima IPS S.A.S
• Germany
  • Hamburg, Germany, 22041
    • Cardiologicum Hamburg - Praxen Wandsbek
  • Bayern
    • Würzburg, Bayern, Germany, 97078
      • Klinikum der Universität Würzburg
  • Brandenburg
    • Elsterwerda, Brandenburg, Germany, 04910
      • Zentrum für klinische Studien Südbrandenburg GmbH
  • Nordrhein-Westfalen
    • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
      • Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
      • Kliniken Maria Hilf GmbH
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz
  • Sachsen
    • Dresden, Sachsen, Germany, 01069
      • Klinische Forschung Dresden GmbH
• Greece
  • Athens, Greece, 11527
    • G. GENNIMATAS General State Hospital of Athens
  • Larissa, Greece, 41100
    • University General Hospital of Larissa
  • Nea Ionia / Athens, Greece, 142 33
    • Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
  • Thessaloniki, Greece, 54642
    • Hippokration General Hospital of Thessaloniki
  • Thessaloniki, Greece, 54636
    • "AHEPA" University General Hospital of Thessaloniki
  • Attica
    • Kifisia / Athens, Attica, Greece, 14561
      • KAT General Hospital of Athens
• Hungary
  • Budapest, Hungary, 1134
    • Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
  • Budapest, Hungary, 1027
    • Budai Irgalmasrendi Korhaz
  • Budapest, Hungary
    • Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
  • Gyongyos, Hungary, 3200
    • Pharma4Trial Kft.
  • Nagykanizsa, Hungary, 8800
    • Kanizsai Dorottya Hospital
  • Nyiregyhaza, Hungary, 4400
    • Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
• Israel
  • Afula, Israel, 1834111
    • Haemek Medical Center
  • Hadera, Israel, 3810101
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Corporation
  • Jerusalem, Israel, 9112001
    • Hadassah Hebrew University Hospital Ein Kerem
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
  • Tiberias, Israel, 1528001
    • The Baruch Padeh Medical Center, Poria
  • Zefat, Israel, 1311001
    • Health Corporation of the Ziv Medical Center (R.A.)
  • Zrifin, Israel, 7030000
    • Shamir Medical Center (Assaf Harofeh)
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • A.O.U. di Bologna Policlinico S.Orsola Malpighi
    • Ferrara, Emilia-Romagna, Italy, 44124
      • A.O.U. di Ferrara
  • Lazio
    • Roma, Lazio, Italy, 00040
      • Asl Roma 6
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • ASST Papa Giovanni XXIII
    • Brescia, Lombardia, Italy, 25123
      • Asst Spedali Civili Di Brescia
    • Milano, Lombardia, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda
    • Milano, Lombardia, Italy, 20089
      • IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
    • Pavia, Lombardia, Italy, 27100
      • Irccs Fondazione Policlinico San Matteo
  • Sardegna
    • Sassari, Sardegna, Italy, 07100
      • A.O.U. di Sassari
• Japan
  • Fukui, Japan, 910-8526
    • Fukui Prefectural Hospital
  • Okayama, Japan, 702-8055
    • Okayama Rosai Hospital
  • Osaka, Japan, 558-8558
    • Osaka General Medical Center
  • Toyama, Japan, 930-8550
    • Toyama Prefectural Central Hospital
  • Chiba
    • Matsudo, Chiba, Japan, 271-0077
      • Seikeikai New Tokyo Heart Clinic
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 805-8508
      • Steel Memorial Yawata Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0026
      • Matsuda Cardiovascular Clinic
  • Hyogo
    • Kobe, Hyogo, Japan, 654-0155
      • National Hospital Organization Kobe Medical Center
    • Takarazuka, Hyogo, Japan, 665-0873
      • Higashi Takarazuka Satoh Hospital
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8650
      • National Hospital Organization Kanazawa Medical Center
  • Iwate
    • Morioka, Iwate, Japan, 020-0066
      • Iwate Prefectural Central Hospital
  • Kyoto
    • Uji, Kyoto, Japan, 611-0041
      • Uji-Tokushukai Medical Center
  • Osaka
    • Hirakata, Osaka, Japan, 573-0153
      • Hirakata kohsai Hospital
    • Kishiwada, Osaka, Japan, 596-0042
      • Kishiwada Tokushukai Hospital
    • Takatsuki, Osaka, Japan, 569-1096
      • Takatsuki Red Cross Hospital
    • Takatsuki, Osaka, Japan, 569-8686
      • Osaka Medical College Hospital
  • Shimane
    • Hamada, Shimane, Japan, 697-8511
      • National Hospital Organization Hamada Medical Center
  • Tokyo
    • Hachioji, Tokyo, Japan, 192-0918
      • Minamino Cardiovascular Hospital
    • Ota-ku, Tokyo, Japan, 143-8541
      • Toho University Omori Medical Center
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital
  • Yamaguchi
    • Iwakuni, Yamaguchi, Japan, 740-8510
      • National Hospital Organization Iwakuni Clinical Center
• Malaysia
  • Kelantan, Malaysia, 15200
    • Hospital Raja Perempuan Zainab II
  • Kuala Lumpur, Malaysia, 50400
    • Institute Jantung Negara
  • Sarawak, Malaysia, 94300
    • Sarawak Heart Centre
• Poland
  • Bialystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny W Bialymstoku
  • Bydgoszcz, Poland, 85-681
    • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
  • Katowice, Poland, 40-156
    • CLINICAL MEDICAL RESEARCH Sp. z o. o.
  • Lodz, Poland, 92-213
    • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
  • Poznan, Poland, 61-848
    • Szpital Kliniczny Przemienienia Pańskiego
  • Szczecin, Poland, 70-240
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Warszawa, Poland, 02-097
    • Uniwersyteckie Centrum Kliniczne Warszawskiego UM
  • Wroclaw, Poland, 50-981
    • IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
  • Wroclaw, Poland, 54-049
    • Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej
• Portugal
  • Almada, Portugal, 2801-951
    • Hospital Garcia de Orta
  • Lisboa, Portugal, 1449-005
    • CHLO - Hospital Sao Francisco Xavier
  • Lisboa, Portugal, 1500-650
    • Hospital da Luz - Lisboa
  • Porto, Portugal, 4099-001
    • CHUP - Hospital Santo Antonio
  • Lisboa
    • Alcabideche, Lisboa, Portugal, 2755-009
      • Hospital de Cascais
  • Porto
    • Guilhufe, Porto, Portugal, 4564-007
      • CHTS - Hospital Padre Americo
  • Setúbal
    • Setubal, Setúbal, Portugal, 2900-446
      • CHS - Hospital Sao Bernardo
• Russian Federation
  • Kemerovo, Russian Federation, 650002
    • Sci-Res. Institute of Complex Cardiovascular Disorders
  • Moscow, Russian Federation, 119192
    • Moscow State University n.a. M.V. Lomonosov
  • Moscow, Russian Federation, 101990
    • Research center of therapy and prophylactic medicine
  • Samara, Russian Federation, 443070
    • Samara Regional Clinical Cardiology Dispensary n.a. Polyakov
  • St. Petersburg, Russian Federation, 198205
    • City Hospital #15
  • St. Petersburg, Russian Federation, 199106
    • City Pokrovskaya Hospital
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 169609
    • National Heart Centre Singapore
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa
      • Clinical Trial Systems
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4067
      • Durban Medical Centre
    • Merebank, Kwazulu-Natal, South Africa, 4052
      • Nash Ranjith Research Centre
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • TREAD Research CC
    • Cape Town, Western Cape, South Africa, 7531
      • Tiervlei Trial Centre
    • Somerset West, Western Cape, South Africa, 7130
      • Vergelegen Medi-Clinic
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Málaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Sevilla, Spain, 41014
    • Complejo Hospitalario Ntra. Sra. de Valme
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Clinico Universitario de Santiago de Compostela
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Ciutat Sanitaria i Universitaria de Bellvitge
    • Sant Joan Despi, Barcelona, Spain, 08940
      • Hospital Sant Joan Despi Moises Broggi
  • Madrid
    • Aravaca, Madrid, Spain, 28023
      • Hospital Sanitas La Zarzuela
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Clinica Puerta de Hierro
  • Pontevedra
    • Babio - Beade, Pontevedra, Spain, 36312
      • Hospital Alvaro Cunqueiro
• Taiwan
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 112
    • Cheng Hsin General Hospital
  • Taipei, Taiwan, 10016
    • National Taiwan University Hospital
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • WestSide Medical
    • Carmichael, California, United States, 95608
      • Capitol Interventional Cardiology
    • West Hills, California, United States, 91307
      • Interventional Cardiology Medical Group
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Penrose-St. Francis Health Services
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • Cardiology Associates of Fairfield County, PC
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Cardiology Associates Of South Florida PA
    • Bradenton, Florida, United States, 34209
      • Cardiovascular and Vein Center of Florida
    • Daytona Beach, Florida, United States, 32117
      • Cardiology Associates Research Company
    • Miami, Florida, United States, 33130
      • LifeSpring Research Foundation, LLC
    • Naples, Florida, United States, 34102
      • Southwest Florida Research
    • Saint Augustine, Florida, United States, 32086
      • East Coast Institute For Research, LLC
    • Wellington, Florida, United States, 33449
      • Cardiology Partners
  • Illinois
    • Aurora, Illinois, United States, 60506
      • Fox Valley Clinical Research Center, LLC
    • Libertyville, Illinois, United States, 60048
      • Advocate Condell Medical Center
  • Indiana
    • Richmond, Indiana, United States, 47374
      • Reid Health
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Louisiana
    • Hammond, Louisiana, United States, 70403
      • Heart Clinic of Hammond
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Health System
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Mississippi
    • Picayune, Mississippi, United States, 39466
      • Riser Medical Associates
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart & Vascular, PC
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research, LLC
  • South Carolina
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular Center
  • Texas
    • San Antonio, Texas, United States, 78212-4740
      • Clinical Advancement Center, PLLC
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Corporation Lane Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vericiguat up to 10 mg; 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.	Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets; Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.
Experimental: Vericiguat up to 15 mg; 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.	Drug: Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets; Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.
Placebo Comparator: Placebo; Subject will receive placebo for 24 weeks, once daily, starting sham up-titration at weeks 2, 4, and 6.	Drug: Placebo; Placebo and sham up-titration at weeks 2, 4, and 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events	An AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation patient after providing written informed consent for participation in the study. Adverse events are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 5 calendar days after end of treatment with study medication.	From first application of study drug up to 5 calendar days after end of treatment with study drug

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Merck Sharp & Dohme LLC; Duke Clinical Research Institute; Canadian VIGOUR Centre

Publications and helpful links

General Publications

• Butler J, Lam CSP, Anstrom KJ, Ezekowitz J, Hernandez AF, O'Connor CM, Pieske B, Ponikowski P, Shah SJ, Solomon SD, Voors AA, Wu Y, Carvalho F, Bamber L, Blaustein RO, Roessig L, Armstrong PW. Rationale and Design of the VITALITY-HFpEF Trial. Circ Heart Fail. 2019 May;12(5):e005998. doi: 10.1161/CIRCHEARTFAILURE.119.005998.
• Armstrong PW, Lam CSP, Anstrom KJ, Ezekowitz J, Hernandez AF, O'Connor CM, Pieske B, Ponikowski P, Shah SJ, Solomon SD, Voors AA, She L, Vlajnic V, Carvalho F, Bamber L, Blaustein RO, Roessig L, Butler J; VITALITY-HFpEF Study Group. Effect of Vericiguat vs Placebo on Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The VITALITY-HFpEF Randomized Clinical Trial. JAMA. 2020 Oct 20;324(15):1512-1521. doi: 10.1001/jama.2020.15922. Erratum In: JAMA. 2021 Feb 2;325(5):494.

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): November 4, 2019

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: May 24, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 19334; 2018-000298-65 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No