Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT ID: NCT06122779
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
208 participants
INTERVENTIONAL
2023-11-07
2026-07-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986435
BMS-986435
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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BMS-986435
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
85 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Local Institution - 0099
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
Local Institution - 0095
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
Local Institution - 0054
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
Local Institution - 0102
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 of Zhejiang University School of Medicine
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
Napoli, 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
Local Institution - 0098
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
Local Institution - 0072
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
Local Institution - 0065
Stockton-on-Tees, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Pankaj Arora, Site 0002
Role: primary
McHale Anderson, Site 0096
Role: primary
Nima Taghipour, Site 0077
Role: primary
Site 0099
Role: primary
Ravi Patel, Site 0004
Role: primary
Suhail Khadra, Site 0005
Role: primary
Ashwin Ravichandran, Site 0029
Role: primary
Harvey Serota, Site 0028
Role: primary
Site 0117
Role: primary
Eugene Pashkovetsky, Site 0070
Role: primary
Site 0105
Role: primary
Parag Goyal, Site 0008
Role: primary
Christopher Cove, Site 0059
Role: primary
Vishal Parikh, Site 0076
Role: primary
Olakunle Akinboboye, Site 0094
Role: primary
Site 0095
Role: primary
Naeem Tahirkheli, Site 0016
Role: primary
Donald Haas, Site 0078
Role: primary
Dinesh Gupta, Site 0001
Role: primary
Site 0104
Role: primary
Ambarish Pandey, Site 0036
Role: primary
Amin Karim, Site 0015
Role: primary
Site 0054
Role: primary
Site 0115
Role: primary
Site 0090
Role: primary
Site 0053
Role: primary
Site 0073
Role: primary
Lilia Luz Lobo Marquez, Site 0061
Role: primary
Claudio Majul, Site 0060
Role: primary
Site 0067
Role: primary
Hugo Colombo, Site 0074
Role: primary
Site 0069
Role: primary
Site 0102
Role: primary
Catherine Demers, Site 0007
Role: primary
Gordon Moe, Site 0037
Role: primary
Zhuang Tian, Site 0089
Role: primary
Zhicheng Jing, Site 0087
Role: primary
Laijing Du, Site 0080
Role: primary
Daoquan Peng, Site 0079
Role: primary
JianAn Wang, Site 0082
Role: primary
Site 0109
Role: primary
Site 0113
Role: primary
Site 0111
Role: primary
Site 0112
Role: primary
Site 0108
Role: primary
Site 0110
Role: primary
Site 0106
Role: primary
Site 0116
Role: primary
Massimo Piepoli, Site 0022
Role: primary
Tomofumi Takaya, Site 0092
Role: primary
Takahiro Saeki, Site 0100
Role: primary
Mitsuru Munemasa, Site 0091
Role: primary
Satoshi Kuroyanagi, Site 0093
Role: primary
Haruhiko Onaka, Site 0103
Role: primary
Jaroslaw Drozdz, Site 0013
Role: primary
Jae-Hyeong Park, Site 0084
Role: primary
Sung-Hee Shin, Site 0056
Role: primary
Seok-Min Kang, Site 0085
Role: primary
Jong-Chan Youn, Site 0055
Role: primary
Sang-Chol Lee, Site 0114
Role: primary
Jung-Hyun Choi, Site 0086
Role: primary
Incheol Kim, Site 0088
Role: primary
Kye Hun Kim, Site 0083
Role: primary
Site 0098
Role: primary
Hyung-Kwan Kim, Site 0081
Role: primary
Domingo Pascual-Figal, Site 0021
Role: primary
Antonio Reyes Dominguez, Site 0018
Role: primary
Jaymin Shah, Site 0063
Role: primary
Thomas Green, Site 0071
Role: primary
Site 0072
Role: primary
Eva Sammut, Site 0101
Role: primary
Site 0097
Role: primary
Site 0075
Role: primary
Andrew Lewis, Site 0062
Role: primary
Site 0065
Role: primary
Sandeep Hothi, Site 0064
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-505919-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1292-8451
Identifier Type: OTHER
Identifier Source: secondary_id
CV029-1001
Identifier Type: -
Identifier Source: org_study_id