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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
227
Start Date
2023-11-07
Completion Date
2026-12-14
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
BMS-986435
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (86)
Local Institution - 0002
Birmingham, Alabama, United States
Local Institution - 0096
Lakewood, Colorado, United States
Local Institution - 0077
Jacksonville, Florida, United States
Local Institution - 0003
Miami, Florida, United States
Local Institution - 0099
Miami, Florida, United States
Local Institution - 0004
Chicago, Illinois, United States
Local Institution - 0005
Hazel Crest, Illinois, United States
Local Institution - 0029
Indianapolis, Indiana, United States
Local Institution - 0028
St Louis, Missouri, United States
Local Institution - 0117
Hackensack, New Jersey, United States
Local Institution - 0070
Albany, New York, United States
Local Institution - 0105
Brooklyn, New York, United States
Local Institution - 0008
New York, New York, United States
Local Institution - 0059
Rochester, New York, United States
Local Institution - 0076
Rochester, New York, United States
Local Institution - 0094
Rosedale, New York, United States
Local Institution - 0095
Durham, North Carolina, United States
Local Institution - 0016
Oklahoma City, Oklahoma, United States
Local Institution - 0078
Abington, Pennsylvania, United States
Local Institution - 0001
Tullahoma, Tennessee, United States
Local Institution - 0104
Austin, Texas, United States
Local Institution - 0036
Dallas, Texas, United States
Local Institution - 0015
Houston, Texas, United States
Local Institution - 0054
Ciudad del Libertador General San Martin, 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
Local Institution - 0061
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0060
Buenos Aires, Argentina
Local Institution - 0067
Buenos Aires, Argentina
Local Institution - 0074
Córdoba, Argentina
Local Institution - 0069
Salta, Argentina
Local Institution - 0102
Santa Fe, Argentina
Local Institution - 0007
Hamilton, Ontario, Canada
Local Institution - 0037
Toronto, Ontario, Canada
Local Institution - 0089
Beijing, Beijing Municipality, China
Local Institution - 0087
Guangzhou, Guangdong, China
Local Institution - 0080
Luoyang, Henan, China
Local Institution - 0079
Changsha, Hunan, China
Local Institution - 0082
Hangzhou, Zhejiang, China
Local Institution - 0109
Jerusalem, Jerusalem, Israel
Local Institution - 0111
Beersheba, Israel
Local Institution - 0112
Be’er Ya‘aqov, Israel
Local Institution - 0108
Haifa, Israel
Local Institution - 0113
Jerusalem, Israel
Local Institution - 0110
Petah Tikva, Israel
Local Institution - 0106
Rehovot, Israel
Local Institution - 0116
Safed, Israel
Local Institution - 0019
Naples, Campania, Italy
Local Institution - 0022
San Donato Milanese, Lombardy, Italy
Local Institution - 0017
Pisa, Tuscany, Italy
Local Institution - 0009
Bergamo, Italy
Local Institution - 0092
Himeji-Shi, Hyōgo, Japan
Local Institution - 0100
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0091
Okayama, Okayama-ken, Japan
Local Institution - 0093
Kishiwada, Osaka, Japan
Local Institution - 0103
Takatsuki-Shi, Osaka, Japan
Local Institution - 0013
Lódz, Lódzkie, Poland
Local Institution - 0031
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0086
Pusan, Busan Gwangyeogsi, South Korea
Local Institution - 0084
Daejeon, Daejeon Gwang'yeogsi, South Korea
Local Institution - 0083
Gwangju, Gwangju Gwang'yeogsi, South Korea
Local Institution - 0098
Seongnam, Gyeonggido, South Korea
Local Institution - 0056
Junggu, Incheon Gwang'yeogsi, South Korea
Local Institution - 0081
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0085
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0114
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0055
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 0088
Daegu, South Korea
Local Institution - 0012
L'Hospitalet de Llobregat, Barcelona, Spain
Local Institution - 0025
Majadahonda, Madrid, Spain
Local Institution - 0021
El Palmar, Murcia, Spain
Local Institution - 0026
Madrid, Spain
Local Institution - 0032
Málaga, Spain
Local Institution - 0018
Seville, Spain
Local Institution - 0010
Valencia, Spain
Local Institution - 0063
Harrow, Greater London, United Kingdom
Local Institution - 0071
North Shields, Northumberland, United Kingdom
Local Institution - 0072
Leeds, Yorkshire, United Kingdom
Local Institution - 0101
Bristol, United Kingdom
Local Institution - 0097
Dundee, United Kingdom
Local Institution - 0075
London, United Kingdom
Local Institution - 0062
Oxford, United Kingdom
Local Institution - 0065
Stockton-on-Tees, United Kingdom
Local Institution - 0064
Wolverhampton, United Kingdom