Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
- Registration Number
- NCT06122779
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 198
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BMS-986435 BMS-986435 -
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (TEAEs) Up to approximately 24 weeks Incidence of serious adverse events (SAEs) Up to approximately 24 weeks Incidence of AEs leading to treatment discontinuation Up to approximately 20 weeks
- Secondary Outcome Measures
Name Time Method Summary of plasma concentrations of MYK-224 Up to approximately 20 weeks
Trial Locations
- Locations (107)
University of Alabama at Birmingham
๐บ๐ธBirmingham, Alabama, United States
Local Institution - 0096
๐บ๐ธLakewood, Colorado, United States
Local Institution - 0077
๐บ๐ธJacksonville, Florida, United States
Infinite Clinical Research
๐บ๐ธMiami, Florida, United States
Local Institution - 0099
๐บ๐ธMiami, Florida, United States
Local Institution - 0014
๐บ๐ธAtlanta, Georgia, United States
Local Institution - 0048
๐บ๐ธAtlanta, Georgia, United States
Bluhm Cardiovascular Institute of Northwestern
๐บ๐ธChicago, Illinois, United States
Chicago Medical Research, LLC
๐บ๐ธHazel Crest, Illinois, United States
Ascension Medical Group St. Vincent - Indianapolis Heart Care
๐บ๐ธIndianapolis, Indiana, United States
Local Institution - 0045
๐บ๐ธIndianapolis, Indiana, United States
St. Louis Heart and Vascular
๐บ๐ธSaint Louis, Missouri, United States
Local Institution - 0043
๐บ๐ธSaint Louis, Missouri, United States
Local Institution - 0070
๐บ๐ธAlbany, New York, United States
Local Institution - 0105
๐บ๐ธBrooklyn, New York, United States
Weill Cornell Medicine
๐บ๐ธNew York, New York, United States
Local Institution - 0059
๐บ๐ธRochester, New York, United States
Local Institution - 0076
๐บ๐ธRochester, New York, United States
Local Institution - 0094
๐บ๐ธRosedale, New York, United States
Local Institution - 0095
๐บ๐ธDurham, North Carolina, United States
Local Institution - 0058
๐บ๐ธCincinnati, Ohio, United States
Local Institution - 0041
๐บ๐ธOklahoma City, Oklahoma, United States
South Oklahoma Heart Research
๐บ๐ธOklahoma City, Oklahoma, United States
Local Institution - 0078
๐บ๐ธAbington, Pennsylvania, United States
Tennessee Center for Clinical Trials
๐บ๐ธTullahoma, Tennessee, United States
Local Institution - 0104
๐บ๐ธAustin, Texas, United States
University of Texas Southwestern Medical Center
๐บ๐ธDallas, Texas, United States
Angiocardiac Care of Texas - PA - PPDS
๐บ๐ธHouston, Texas, United States
Local Institution - 0051
๐บ๐ธHouston, Texas, United States
Local Institution - 0066
๐บ๐ธFalls Church, Virginia, United States
Local Institution - 0060
๐ฆ๐ทCiudad Autรณnoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0054
๐ฆ๐ทGeneral San Martรญn, Buenos Aires, Argentina
Local Institution - 0107
๐ฆ๐ทZรกrate, Buenos Aires, Argentina
Local Institution - 0090
๐ฆ๐ทCรณrdoba, Cordoba, Argentina
Local Institution - 0053
๐ฆ๐ทCรณrdoba, Cordoba, Argentina
Local Institution - 0073
๐ฆ๐ทRosario, Santa FE, Argentina
Local Institution - 0061
๐ฆ๐ทSan Miguel De Tucumรกn, Tucuman, Argentina
Local Institution - 0067
๐ฆ๐ทCiudad Autonoma de Buenos Aires, Argentina
Local Institution - 0068
๐ฆ๐ทCiudad Autรณnoma de Buenos Aires, Argentina
Local Institution - 0074
๐ฆ๐ทCรณrdoba, Argentina
Local Institution - 0069
๐ฆ๐ทSalta, Argentina
Local Institution - 0102
๐ฆ๐ทSanta Fe, Argentina
Hamilton General Hospital
๐จ๐ฆHamilton, Ontario, Canada
Medicus MFC Inc.
๐จ๐ฆToronto, Ontario, Canada
Local Institution - 0030
๐จ๐ฆToronto, Ontario, Canada
Local Institution - 0040
๐จ๐ฆToronto, Ontario, Canada
Local Institution - 0011
๐จ๐ฆMontreal, Quebec, Canada
Local Institution - 0035
๐จ๐ฆTrois-Rivieres, Quebec, Canada
Peking Union Medical College Hospital
๐จ๐ณBeijing, Beijing, China
Local Institution - 0087
๐จ๐ณGuangzhou, Guangdong, China
Local Institution - 0080
๐จ๐ณLuoyang, Henan, China
Local Institution - 0079
๐จ๐ณChangsha, Hunan, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
๐จ๐ณHangzhou, Zhejiang, China
Local Institution - 0106
๐ฎ๐ฑRehovot, Israel
Local Institution - 0019
๐ฎ๐นNapoli, Campania, Italy
Local Institution - 0023
๐ฎ๐นMilano, Lombardia, Italy
Local Institution - 0033
๐ฎ๐นMilano, Lombardia, Italy
IRCCS Policlinico San Donato
๐ฎ๐นSan Donato Milanese, Lombardia, Italy
Local Institution - 0050
๐ฎ๐นSan Donato Milanese, Lombardia, Italy
Local Institution - 0027
๐ฎ๐นFoggia, Puglia, Italy
Local Institution - 0038
๐ฎ๐นFoggia, Puglia, Italy
Local Institution - 0052
๐ฎ๐นMassa, Toscana, Italy
Local Institution - 0009
๐ฎ๐นBergamo, Italy
Local Institution - 0017
๐ฎ๐นPisa, Italy
Local Institution - 0092
๐ฏ๐ตHimeji-Shi, Hyogo, Japan
Local Institution - 0100
๐ฏ๐ตKanazawa, Ishikawa, Japan
Local Institution - 0091
๐ฏ๐ตOkayama-Shi, Okayama, Japan
Local Institution - 0093
๐ฏ๐ตKishiwada, Osaka, Japan
Local Institution - 0103
๐ฏ๐ตTakatsuki-Shi, Osaka, Japan
Local Institution - 0088
๐ฐ๐ทDaegu, Daegu Gwang'yeogsi, Korea, Republic of
Local Institution - 0084
๐ฐ๐ทDaejeon, Daejeon Gwang'yeogsi, Korea, Republic of
Local Institution - 0083
๐ฐ๐ทGwangju, Gwangju Gwang'yeogsi, Korea, Republic of
Inha University Hospital
๐ฐ๐ทJung-gu, Incheon Gwang'yeogsi, Korea, Republic of
Local Institution - 0085
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 0055
๐ฐ๐ทSeoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 0086
๐ฐ๐ทBusan, Korea, Republic of
Local Institution - 0098
๐ฐ๐ทSeongnam-si, Korea, Republic of
Local Institution - 0081
๐ฐ๐ทSeoul, Korea, Republic of
Clinical Trials UMED Sp. z o.o.
๐ต๐ฑLรณdz, Lรณdzkie, Poland
Local Institution - 0031
๐ต๐ฑBialystok, Podlaskie, Poland
Local Institution - 0044
๐ต๐ฑBialystok, Podlaskie, Poland
Local Institution - 0020
๐ต๐ฑLublin, Woj. Lubelskie, Poland
Local Institution - 0049
๐ต๐ฑLublin, Woj. Lubelskie, Poland
Local Institution - 0006
๐ต๐ฑKrakow, Poland
Local Institution - 0024
๐ต๐ฑOswiecim, Poland
Local Institution - 0012
๐ช๐ธHospitalet de Llobregat, Barcelona, Spain
Local Institution - 0025
๐ช๐ธMajadahonda, Madrid, Spain
Local Institution - 0047
๐ช๐ธMajadahonda, Madrid, Spain
Hospital Universitario Virgen de La Arrixaca
๐ช๐ธEl Palmar, Murcia, Spain
Local Institution - 0039
๐ช๐ธEl Palmar, Murcia, Spain
Local Institution - 0042
๐ช๐ธMalaga, Mรกlaga, Spain
Local Institution - 0026
๐ช๐ธMadrid, Spain
Local Institution - 0034
๐ช๐ธMadrid, Spain
Local Institution - 0032
๐ช๐ธMalaga, Spain
Hospital Nuestra Seรฑora de Valme
๐ช๐ธSevilla, Spain
Local Institution - 0046
๐ช๐ธSevilla, Spain
Local Institution - 0010
๐ช๐ธValencia, Spain
Local Institution - 0063
๐ฌ๐งHarrow, Greater London, United Kingdom
Local Institution - 0071
๐ฌ๐งNorth Shields, Northumberland, United Kingdom
Local Institution - 0062
๐ฌ๐งOxford, Oxfordshire, United Kingdom
Local Institution - 0072
๐ฌ๐งLeeds, Yorkshire, United Kingdom
Local Institution - 0057
๐ฌ๐งSheffield, Yorkshire, United Kingdom
Local Institution - 0101
๐ฌ๐งBristol, United Kingdom
Local Institution - 0097
๐ฌ๐งDundee, United Kingdom
Local Institution - 0075
๐ฌ๐งLondon, United Kingdom
Local Institution - 0065
๐ฌ๐งStockton-On-Tees, United Kingdom
Local Institution - 0064
๐ฌ๐งWolverhampton, United Kingdom