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Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).
Official title: A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Key Details
Gender
All
Age Range
40 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
208
Start Date
2023-11-07
Completion Date
2026-07-03
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
BMS-986435
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (117)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Colorado Heart and Vascular - Lakewood
Lakewood, Colorado, United States
Ascension St. Vincent's Riverside Hospital - PPDS
Jacksonville, Florida, United States
Local Institution - 0003
Miami, Florida, United States
University of Miami FL Miller School of Medicine -1120 NW 14th St
Miami, Florida, United States
Local Institution - 0014
Atlanta, Georgia, United States
Local Institution - 0048
Atlanta, Georgia, United States
Bluhm Cardiovascular Institute of Northwestern
Chicago, Illinois, United States
Chicago Medical Research, LLC - Hazel Crest
Hazel Crest, Illinois, United States
Ascension Medical Group St. Vincent - Indianapolis Heart Care
Indianapolis, Indiana, United States
Local Institution - 0045
Indianapolis, Indiana, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Local Institution - 0043
St Louis, Missouri, United States
Local Institution - 0117
Hackensack, New Jersey, United States
Capital Cardiology Associates
Albany, New York, United States
Local Institution - 0105
Brooklyn, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of Rochester Medical Center - PPDS
Rochester, New York, United States
Rochester General Hospital Center for Clinical Research
Rochester, New York, United States
Laurelton Heart Specialist PC - MyClinical - PPDS
Rosedale, New York, United States
Duke Cardiology Clinic - PPDS
Durham, North Carolina, United States
Local Institution - 0058
Cincinnati, Ohio, United States
Local Institution - 0041
Oklahoma City, Oklahoma, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
Local Institution - 0104
Austin, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Angiocardiac Care of Texas - PA - PPDS
Houston, Texas, United States
Local Institution - 0051
Houston, Texas, United States
Local Institution - 0066
Falls Church, Virginia, United States
Corporación Médica de General San Martín
Ciudad del Libertador General San Martín, Buenos Aires, Argentina
Local Institution - 0107
Zárate, Buenos Aires, Argentina
Local Institution - 0115
Zárate, Buenos Aires, Argentina
Local Institution - 0090
Córdoba, Córdoba Province, Argentina
Local Institution - 0053
Córdoba, Córdoba Province, Argentina
Local Institution - 0073
Rosario, Santa Fe Province, Argentina
IPR-Investigaciones en Patologías Respiratorias
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Especialidades Médicas CEMEDIC
Buenos Aires, Argentina
Local Institution - 0068
Buenos Aires, Argentina
Local Institution - 0067
Buenos Aires, Argentina
Sanatorio Duarte Quiros
Córdoba, Argentina
Local Institution - 0069
Salta, Argentina
Centro de Investigaciones Clínicas Del Litoral SRL
Santa Fe, Argentina
Hamilton General Hospital
Hamilton, Ontario, Canada
Medicus MFC Inc.
Toronto, Ontario, Canada
Local Institution - 0030
Toronto, Ontario, Canada
Local Institution - 0040
Toronto, Ontario, Canada
Local Institution - 0011
Montreal, Quebec, Canada
Local Institution - 0035
Trois-Rivières, Quebec, Canada
Peking Union Medical College Hospital - East Campus
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Affiliated Hospital, Zhejiang University School of Medicine - Jiefanglu Campus
Hangzhou, Zhejiang, China
Local Institution - 0109
Jerusalem, Jerusalem, Israel
Local Institution - 0113
Jerusalem, Jerusalem, Israel
Local Institution - 0111
Beersheba, Israel
Local Institution - 0112
Be’er Ya‘aqov, Israel
Local Institution - 0108
Haifa, Israel
Local Institution - 0110
Petah Tikva, Israel
Local Institution - 0106
Rehovot, Israel
Local Institution - 0116
Safed, Israel
Local Institution - 0027
Foggia, Apulia, Italy
Local Institution - 0038
Foggia, Apulia, Italy
Local Institution - 0019
Naples, Campania, Italy
Local Institution - 0023
Milan, Lombardy, Italy
Local Institution - 0033
Milan, Lombardy, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Lombardy, Italy
Local Institution - 0050
San Donato Milanese, Lombardy, Italy
Local Institution - 0052
Massa, Tuscany, Italy
Local Institution - 0009
Bergamo, Italy
Local Institution - 0017
Pisa, Italy
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji-Shi, Hyōgo, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, Japan
Okayama Rosai Hospital
Okayama, Okayama-ken, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Takatsuki Red Cross Hospital
Takatsuki-Shi, Osaka, Japan
Clinical Trials UMED Sp. z o.o.
Lódz, Lódzkie, Poland
Local Institution - 0031
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0044
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0020
Lublin, Woj. Lubelskie, Poland
Local Institution - 0049
Lublin, Woj. Lubelskie, Poland
Local Institution - 0006
Krakow, Poland
Local Institution - 0024
Oświęcim, Poland
Chungnam National University Hospital
Daejeon, Daejeon Gwang'yeogsi, South Korea
Inha University Hospital
Junggu, Incheon Gwang'yeogsi, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Pusan National University Hospital
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Seoul National University Hospital
Seoul, South Korea
Local Institution - 0012
L'Hospitalet de Llobregat, Barcelona, Spain
Local Institution - 0025
Majadahonda, Madrid, Spain
Local Institution - 0047
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, Spain
Local Institution - 0039
El Palmar, Murcia, Spain
Local Institution - 0042
Málaga, Málaga, Spain
Local Institution - 0026
Madrid, Spain
Local Institution - 0034
Madrid, Spain
Local Institution - 0032
Málaga, Spain
Hospital Nuestra Señora de Valme
Seville, Spain
Local Institution - 0046
Seville, Spain
Local Institution - 0010
Valencia, Spain
Northwick Park Hospital
Harrow, Greater London, United Kingdom
North Tyneside General Hospital
North Shields, Northumberland, United Kingdom
Leeds General Infirmary - PPDS
Leeds, Yorkshire, United Kingdom
Local Institution - 0057
Sheffield, Yorkshire, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Local Institution - 0097
Dundee, United Kingdom
Local Institution - 0075
London, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom