check_circleStudy Completed
Chronic heart failure with preserved ejection fraction
Bayer Identifier:
19334
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Patient-reported outcomes in vericiguat-treated patients with HFpEF
Trial purpose
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.
Key Participants Requirements
Sex
AllAge
45 - N/ATrial summary
Enrollment Goal
789Trial Dates
June 2018 - November 2019Phase
Phase 2Could I Receive a placebo
YesProducts
Vericiguat (BAY1021189)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | PACE Cardiology Clinic | Newmarket, L3Y 2P6, Canada |
Completed | Oakville Cardiologists, Inc. | Oakville, L6K 3W7, Canada |
Completed | UZ Antwerpen | EDEGEM, 2650, Belgium |
Completed | AZ St-Jan Brugge Oostende AV | BRUGGE, 8000, Belgium |
Withdrawn | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | AZ Delta | ROESELARE, 8800, Belgium |
Completed | H. Hartziekenhuis Mol | MOL, 2400, Belgium |
Withdrawn | ZNA Middelheim | ANTWERPEN, 2020, Belgium |
Completed | Algemeen Stedelijk Ziekenhuis Campus Aalst | AALST, 9300, Belgium |
Completed | Hospital da Luz - Lisboa | Lisboa, 1500-650, Portugal |
Completed | CHTS - Hospital Padre Americo | Guilhufe, 4564-007, Portugal |
Completed | Complejo Hospitalario Ntra. Sra. de Valme | Sevilla, 41014, Spain |
Completed | Hospital Virgen de la Victoria | Málaga, 29010, Spain |
Completed | Hospital Sanitas La Zarzuela | Aravaca, 28023, Spain |
Completed | Hospital Universitario Clinica Puerta de Hierro | Majadahonda, 28222, Spain |
Completed | Hospital del Mar | Barcelona, 08003, Spain |
Completed | Ciutat Sanitària i Universitària de Bellvitge | L'Hospitalet de Llobregat, 08907, Spain |
Completed | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Withdrawn | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Hospital Álvaro Cunqueiro | Babio - Beade, 36312, Spain |
Completed | Hospital Sant Joan Despi Moises Broggi | Sant Joan Despi, 08940, Spain |
Completed | Centro de Especialidades Médicas | Villa Luro, C1440CFD, Argentina |
Completed | Wake Forest Baptist Health | Winston Salem, 27157, United States |
Withdrawn | Sutter Heart & Vascular Institute | Sacramento, 95816, United States |
Completed | Henry Ford Health System | Detroit, 48202, United States |
Completed | St. Louis Heart & Vascular, PC | St. Louis, 63136, United States |
Completed | Interventional Cardiology Medical Group | West Hills, 91307, United States |
Withdrawn | Sir Mortimer B. Davis Jewish General Hospital | Montreal, H3T 1E2, Canada |
Completed | Clinique Sante Cardio MC | Montreal, H1T 3Y7, Canada |
Completed | London Health Sciences Centre | London, N6A 5A5, Canada |
Completed | Centre De Recherche Du (CRCHUM) - Hotel-Diu | Montreal, H2X 3H8, Canada |
Completed | SMH Cardiology Clinical Trials Inc | Surrey, V3V 0C6, Canada |
Completed | CardioVasc HR, Inc. | Saint-Jean-sur-Richelieu, J3A 1J2, Canada |
Completed | Clínica DIM | Ramos Mejía, B1740ETD, Argentina |
Completed | National Heart Centre Singapore | Singapore, 169609, Singapore |
Completed | Singapore General Hospital | Singapore, 169608, Singapore |
Completed | Klinikum der Universität Würzburg | Würzburg, 97078, Germany |
Completed | Kliniken Maria Hilf GmbH | Mönchengladbach, 41063, Germany |
Completed | Klinische Forschung Dresden GmbH | Dresden, 01069, Germany |
Completed | Zentrum für Klinische Studien Südbrandenburg GmbH | Elsterwerda, 04910, Germany |
Completed | Cardiologicum Hamburg - Praxen Wandsbek | Hamburg, 22041, Germany |
Completed | Marienhaus Klinikum Mainz | Mainz, 55131, Germany |
Withdrawn | Bethanien Krankenhaus | Frankfurt, 60389, Germany |
Withdrawn | University of Iowa Hospitals & Clinics | Iowa City, 52242-1089, United States |
Completed | ASST Papa Giovanni XXIII | Bergamo, 24127, Italy |
Withdrawn | AUSL Toscana Sud-Est | Arezzo, 52044, Italy |
Completed | ASST Spedali Civili di Brescia | Brescia, 25123, Italy |
Completed | A.O.U. di Sassari | Sassari, 07100, Italy |
Completed | ASST Grande Ospedale Metropolitano Niguarda | Milano, 20162, Italy |
Completed | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna, 40138, Italy |
Completed | IRCCS Fondazione Policlinico San Matteo | Pavia, 27100, Italy |
Completed | A.O.U. di Ferrara | Ferrara, 44124, Italy |
Completed | ASL ROMA 6 | Roma, 00040, Italy |
Completed | MHAT Sveta Marina EAD | Varna, 9010, Bulgaria |
Completed | NMTH Tzar Boris III | Sofia, 1233, Bulgaria |
Completed | Specialized Hospital for Actrive Treatm of Card - Pleven | Pleven, 5800, Bulgaria |
Completed | Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik | Pernik, 2300, Bulgaria |
Completed | Second Medical Center Sofia EOOD | Sofia, 1202, Bulgaria |
Completed | Multiprofile Hospital for Active Treatment Pazardzhik | Pazardzhik, 4400, Bulgaria |
Completed | MHAT "Knyaginya Klementina - Sofia"EAD | Sofia, 1233, Bulgaria |
Completed | MHAT Dr. Bratan Shukerov AD | Smolyan, 4700, Bulgaria |
Completed | Multiprofile Hospital for Active Treatment Medline Clinic | Plovdiv, 4000, Bulgaria |
Completed | CHLO - Hospital Sao Francisco Xavier | Lisboa, 1449-005, Portugal |
Completed | CHUP - Hospital Santo Antonio | Porto, 4099-001, Portugal |
Completed | CHS - Hospital Sao Bernardo | Setubal, 2900-446, Portugal |
Completed | Hospital de Cascais | Alcabideche, 2755-009, Portugal |
Completed | Hospital Garcia de Orta | Almada, 2801-951, Portugal |
Completed | Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) | Bad Oeynhausen, 32545, Germany |
Completed | Cardiology Partners | Wellington, 33449, United States |
Completed | East Coast Institute for Research, LLC | St. Augustine, 32086, United States |
Withdrawn | East Coast Institute for Research, LLC | Jacksonville, 32216, United States |
Withdrawn | Banner – University Medical Center Tucson | Tucson, 85724, United States |
Withdrawn | University of Mississippi Medical Center | Jackson, 39216, United States |
Completed | WestSide Medical | Beverly Hills, 90211, United States |
Completed | Capitol Interventional Cardiology | Carmichael, 95608, United States |
Completed | Cardiovascular CRO Ltd. | Sudbury, P3E 5M4, Canada |
Completed | St. Michael's Hospital Health Centre | Toronto, M5B 1W8, Canada |
Completed | Anne Arundel Health System | Annapolis, 21401, United States |
Completed | Carolina Heart Specialists | Lancaster, 29720, United States |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Universitätsklinikum St. Pölten | St. Pölten, 3100, Austria |
Terminated | Bryan Heart | Lincoln, 68506, United States |
Completed | Fox Valley Clinical Research Center, LLC | Aurora, 60506, United States |
Completed | Penrose-St. Francis Health Services | Colorado Springs, 80923, United States |
Completed | Centro de Investigaciones Clinicas del Litoral | Santa Fe, S3000FWO, Argentina |
Completed | Sanatorio Parque S.A. | Rosario, S2000DSV, Argentina |
Completed | Inst. de Cardiología de Corrientes Juana Francisca Cabral | Corrientes, 3400, Argentina |
Completed | Instituto de Investigaciones Clínicas San Nicolás | San Nicolás, B2900DMH, Argentina |
Completed | IPS Centro Cientifico Asistencial S.A.S | Barranquilla, Colombia |
Terminated | Caja de Compensación Familiar CAFAM | Bogotá, Colombia |
Withdrawn | Rodrigo Botero S.A.S | Medellín, Colombia |
Withdrawn | Fundación Cardiomet CEQUIN Eje Cafetero | Armenia, Colombia |
Completed | Fundación Cardiovascular de Colombia | Floridablanca, Colombia |
Withdrawn | CICLAM | Medellín, Colombia |
Withdrawn | Fundacion Cardiovascular Santa Maria | Medellín, Colombia |
Completed | Hospital General de Medellin | Medellin, Colombia |
Completed | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Withdrawn | Mackay Memorial Hospital - Hsinchu Branch | Hsinchu City, 300, Taiwan |
Completed | Szpital Kliniczny Przemienienia Panskiego | Poznan, 61-848, Poland |
Completed | IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ | Wroclaw, 50-981, Poland |
Completed | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin, 70-240, Poland |
Completed | CLINICAL MEDICAL RESEARCH Sp. z o. o. | Katowice, 40-156, Poland |
Completed | 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ | Bydgoszcz, 85-681, Poland |
Completed | Dolnoslaski Szp. Spec. im T.M. Centrum Medycyny Ratunkowej | Wroclaw, 54-049, Poland |
Completed | SPZOZ Centralny Szpital Kliniczny UM w Lodzi | Lodz, 92-213, Poland |
Withdrawn | SP Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego | Katowice, 40-635, Poland |
Completed | Uniwersyteckie Centrum Kliniczne Warszawskiego UM | Warszawa, 02-097, Poland |
Completed | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok, 15-276, Poland |
Withdrawn | Grace Research, LLC | Bossier City, 71111, United States |
Completed | Zentrum f. klinische Studien Dr. Hanusch GmbH | Wien, 1060, Austria |
Withdrawn | Klinik Favoriten - Sozialmedizinisches Zentrum Süd | Wien, 1100, Austria |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Ordensklinikum Linz GmbH Elisabethinen | Linz, 4020, Austria |
Completed | Klinik Floridsdorf - Krankenhaus Nord | Wien, 1210, Austria |
Completed | Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz | Budapest, Hungary |
Completed | Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz | Budapest, 1134, Hungary |
Completed | Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft. | Nyiregyhaza, 4400, Hungary |
Completed | Kanizsai Dorottya Hospital | Nagykanizsa, 8800, Hungary |
Completed | Budai Irgalmasrendi Korhaz | Budapest, 1027, Hungary |
Completed | Pharma4Trial Kft. | Gyongyos, 3200, Hungary |
Withdrawn | University General Hospital of Athens "ATTIKON" | Chaidari, 12462, Greece |
Completed | G. GENNIMATAS General State Hospital of Athens | Athens, 11527, Greece |
Completed | Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA | Nea Ionia / Athens, 142 33, Greece |
Completed | KAT General Hospital of Athens | Kifisia / Athens, 14561, Greece |
Completed | University General Hospital of Larissa | Larissa, 41100, Greece |
Completed | Hippokration General Hospital of Thessaloniki | Thessaloniki, 54642, Greece |
Completed | “AHEPA” University General Hospital of Thessaloniki | Thessaloniki, 54636, Greece |
Completed | Glacier View Research Institute | Kalispell, 59901, United States |
Withdrawn | Kent Hospital | Warwick, 02886, United States |
Completed | Krankenhaus St. Josef Braunau | Braunau, 5280, Austria |
Completed | Centro de Investigaciones Clínicas | Buenos Aires, C1425DES, Argentina |
Completed | Shamir Medical Center (Assaf Harofeh) | Zrifin, 7030000, Israel |
Completed | Kaplan Medical Center | Rehovot, 7610001, Israel |
Completed | Rambam Health Corporation | Haifa, 3109601, Israel |
Completed | Hillel Yaffe Medical Center | Hadera, 3810101, Israel |
Completed | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Completed | Rambam Health Corporation | Haifa, 3109601, Israel |
Completed | Chaim Sheba Medical Center | Ramat Gan, 5262000, Israel |
Completed | Clalit Health Services through HaEmek Medical Center | Afula, 1834111, Israel |
Completed | The Baruch Padeh Medical Center, Poriya | Tiberias, 1528001, Israel |
Completed | Health Corporation of the Ziv Medical Center (R.A.) | Zefat, 1311001, Israel |
Completed | Capital Area Research, LLC | Camp Hill, 17011, United States |
Completed | Research Integrity, LLC | Owensboro, 42303, United States |
Withdrawn | Parkway Cardiology Associates, PC | Oak Ridge, 37830, United States |
Completed | Reid Health | Richmond, 47374, United States |
Completed | Cardiology Associates Research Company | Daytona Beach, 32117, United States |
Completed | Southwest Florida Research | Naples, 34102, United States |
Withdrawn | Renown Institute for Heart and Vascular Health | Reno, 89502, United States |
Withdrawn | R.I.A.C Naha City Hospital | Naha, 902-8511, Japan |
Completed | Fukui Prefectural Hospital | Fukui, 910-8526, Japan |
Completed | Osaka General Medical Center | Osaka, 558-8558, Japan |
Completed | Minamino Cardiovascular Hospital | Hachioji, 192-0918, Japan |
Withdrawn | Tokyo Heart Center | Shinagawa-ku, 141-0001, Japan |
Completed | Iwate Prefectural Central Hospital | Morioka, 020-0066, Japan |
Completed | Toho University Omori Medical Center | Ota-ku, 143-8541, Japan |
Completed | Higashi Takarazuka Satoh Hospital | Takarazuka, 665-0873, Japan |
Completed | National Hospital Organization Hamada Medical Center | Hamada, 697-8511, Japan |
Completed | Toyama Prefectural Central Hospital | Toyama, 930-8550, Japan |
Completed | University of Alberta | Edmonton, T6G 2B7, Canada |
Completed | Cardiology Associates of Fairfield County, PC | Trumbull, 06611, United States |
Completed | Heart Clinic of Hammond | Hammond, 70403, United States |
Completed | Stern Cardiovascular Center | Germantown, 38138, United States |
Withdrawn | Grace Research, LLC | Huntsville, 77340, United States |
Completed | National Taiwan University Hospital | Taipei, 100, Taiwan |
Completed | Far Eastern Memorial Hospital | New Taipei City, 220, Taiwan |
Completed | Sci-Res. Institute of Complex Cardiovascular Disorders | Kemerovo, 650002, Russian Federation |
Completed | Research center of therapy and prophylactic medicine | Moscow, 101990, Russian Federation |
Completed | City hospital #15 | St. Petersburg, 198205, Russian Federation |
Completed | Moscow State University n.a. M.V. Lomonosov | Moscow, 119192, Russian Federation |
Completed | Centro de Medicina Integral e Investigacion Clínica | CABA, C1426EGR, Argentina |
Completed | Cheng Hsin General Hospital | Taipei, 112, Taiwan |
Completed | Cardiovascular and Vein Center of Florida | Bradenton, 34209, United States |
Withdrawn | Inova Fairfax Hospital | Falls Church, 22042, United States |
Completed | Durban Medical Centre | Durban, 4067, South Africa |
Withdrawn | Chris Hani Baragwanath Hospital | Johannesburg, 1804, South Africa |
Withdrawn | Groote Schuur Hospital | Cape Town, 7935, South Africa |
Completed | TREAD Research cc | Cape Town, 7500, South Africa |
Completed | Tiervlei Trial Centre | Cape Town, 7531, South Africa |
Completed | Nash Ranjith Research Centre | Merebank, 4052, South Africa |
Completed | Vergelegen Medi-Clinic | Somerset West, 7130, South Africa |
Completed | Clinical Trial Systems | Pretoria, South Africa |
Completed | Mediservis del Tolima IPS S.A.S | Ibague, Colombia |
Completed | Cardiology Associates Of South Florida PA | Boynton Beach, 33472, United States |
Completed | Sarawak Heart Centre | Sarawak, 94300, Malaysia |
Completed | Institute Jantung Negara | Kuala Lumpur, 50400, Malaysia |
Completed | Hospital Raja Perempuan Zainab II | Kelantan, 15200, Malaysia |
Completed | Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. | Milano, 20089, Italy |
Withdrawn | Allegheny General Hospital | Pittsburgh, 15212, United States |
Completed | Advocate Condell Medical Center | Libertyville, 60048, United States |
Withdrawn | PMG Research of DuPage Medical Group | Winfield, 60190, United States |
Withdrawn | University of Nebraska Medical Center | Omaha, 68198-9510, United States |
Withdrawn | Hudson Valley Urology Center | Poughkeepsie, 12601, United States |
Withdrawn | Gleneagles Penang Medical Center | Pulau Pinang, 10050, Malaysia |
Withdrawn | Hospital Tengku Ampuan Afzan | Pahang, 25100, Malaysia |
Completed | Takatsuki Red Cross Hospital | Takatsuki, 569-1096, Japan |
Completed | Kishiwada Tokushukai Hospital | Kishiwada, 596-0042, Japan |
Withdrawn | Hyogo Prefectural Amagasaki General Medical Center | Amagasaki, 660-8550, Japan |
Completed | Tokyo Women's Medical University Hospital | Shinjuku-ku, 162-8666, Japan |
Completed | National Hospital Organization Kanazawa Medical Center | Kanazawa, 920-8650, Japan |
Completed | Okayama Rosai Hospital | Okayama, 702-8055, Japan |
Completed | Osaka Medical College Hospital | Takatsuki, 569-8686, Japan |
Withdrawn | Hutchinson Clinic | Hutchinson, 67502-1131, United States |
Withdrawn | Phillips Medical Services | Jackson, 39209, United States |
Completed | Corporation Lane Research Center | Virginia Beach, 23462, United States |
Completed | LifeSpring Research Foundation, LLC | Miami, 33130, United States |
Withdrawn | M. Reddy Cardiology | Baytown, 77521, United States |
Completed | Matsuda Cardiovascular clinic | Sapporo, 003-0026, Japan |
Completed | Hirakata kohsai Hospital | Hirakata, 573-0153, Japan |
Completed | National Hospital Organization Kobe Medical Center | Kobe, 654-0155, Japan |
Completed | Seikeikai New Tokyo Heart Clinic | Matsudo, 271-0077, Japan |
Withdrawn | Yokohama Minami Kyousai Hospital | Yokohama, 236-0037, Japan |
Completed | Uji-Tokushukai Medical Center | Uji, 611-0041, Japan |
Withdrawn | Yotsuba Circulation Clinic | Matsuyama, 790-0062, Japan |
Completed | Steel Memorial Yawata Hospital | Kitakyushu, 805-8508, Japan |
Completed | Clinical Advancement Center, PLLC | San Antonio, 78212-4740, United States |
Withdrawn | St.Petersburg City hospital ¿38 n.a. N.A. Semashko | St. Petersburg, 196601, Russian Federation |
Withdrawn | Inova Medical Group Cardiology Prosperity | Fairfax, 22031, United States |
Withdrawn | Inova Medical Group - Mt. Vernon | Alexandria, 22306, United States |
Withdrawn | Salem VA Medical Center | Salem, 24153, United States |
Withdrawn | LSU Health Sciences Center New Orleans | New Orleans, 70112, United States |
Completed | City Pokrovskaya Hospital | St. Petersburg, 199106, Russian Federation |
Completed | Samara Regional Clinical Cardiology Dispensary n.a. Polyakov | Samara, 443070, Russian Federation |
Completed | Riser Medical Associates | Picayune, 39466, United States |
Completed | National Hospital Organization Iwakuni Clinical Center | Iwakuni, 740-8510, Japan |
Withdrawn | El Paso Medical Research Institute/ MedResearch, INC | El Paso, 79935, United States |
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.date_rangeTime Frame: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.date_rangeTime Frame:From baseline to Week 24
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3