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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)
NCT06122779 · Bristol-Myers Squibb
In plain English
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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)
About this study
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).
Eligibility criteria
Inclusion Criteria
\- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.
Exclusion Criteria
* Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Study design
Enrollment target: 208 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-11-07
Estimated completion: 2026-07-03
Last updated: 2025-12-15
Interventions
Drug: BMS-986435Other: Placebo
Primary outcomes
- • 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)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (117)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Colorado Heart and Vascular - LakewoodRecruiting
Lakewood, Colorado, United States
Ascension St. Vincent's Riverside Hospital - PPDSRecruiting
Jacksonville, Florida, United States
Local Institution - 0003Active Not Recruiting
Miami, Florida, United States
University of Miami FL Miller School of Medicine -1120 NW 14th StRecruiting
Miami, Florida, United States
Local Institution - 0014Withdrawn
Atlanta, Georgia, United States
Local Institution - 0048Withdrawn
Atlanta, Georgia, United States
Bluhm Cardiovascular Institute of NorthwesternRecruiting
Chicago, Illinois, United States
Chicago Medical Research, LLC - Hazel CrestRecruiting
Hazel Crest, Illinois, United States
Ascension Medical Group St. Vincent - Indianapolis Heart CareRecruiting
Indianapolis, Indiana, United States
Local Institution - 0045Withdrawn
Indianapolis, Indiana, United States
St. Louis Heart and VascularRecruiting
St Louis, Missouri, United States
Local Institution - 0043Withdrawn
St Louis, Missouri, United States
Local Institution - 0117Not Yet Recruiting
Hackensack, New Jersey, United States
Capital Cardiology AssociatesRecruiting
Albany, New York, United States
Local Institution - 0105Not Yet Recruiting
Brooklyn, New York, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
University of Rochester Medical Center - PPDSRecruiting
Rochester, New York, United States
Rochester General Hospital Center for Clinical ResearchRecruiting
Rochester, New York, United States
Laurelton Heart Specialist PC - MyClinical - PPDSRecruiting
Rosedale, New York, United States
Duke Cardiology Clinic - PPDSRecruiting
Durham, North Carolina, United States
Local Institution - 0058Withdrawn
Cincinnati, Ohio, United States
Local Institution - 0041Withdrawn
Oklahoma City, Oklahoma, United States
South Oklahoma Heart ResearchRecruiting
Oklahoma City, Oklahoma, United States
Abington Memorial HospitalRecruiting
Abington, Pennsylvania, United States
Tennessee Center for Clinical TrialsRecruiting
Tullahoma, Tennessee, United States
Local Institution - 0104Not Yet Recruiting
Austin, Texas, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Angiocardiac Care of Texas - PA - PPDSRecruiting
Houston, Texas, United States
Local Institution - 0051Withdrawn
Houston, Texas, United States
Local Institution - 0066Withdrawn
Falls Church, Virginia, United States
Corporación Médica de General San MartínRecruiting
Ciudad del Libertador General San Martin, Buenos Aires, Argentina
Local Institution - 0107Withdrawn
Zárate, Buenos Aires, Argentina
Local Institution - 0115Not Yet Recruiting
Zárate, Buenos Aires, Argentina
Local Institution - 0090Not Yet Recruiting
Córdoba, Córdoba Province, Argentina
Local Institution - 0053Not Yet Recruiting
Córdoba, Córdoba Province, Argentina
Local Institution - 0073Not Yet Recruiting
Rosario, Santa Fe Province, Argentina
IPR-Investigaciones en Patologías RespiratoriasRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Especialidades Médicas CEMEDICRecruiting
Buenos Aires, Argentina
Local Institution - 0068Withdrawn
Buenos Aires, Argentina
Local Institution - 0067Not Yet Recruiting
Buenos Aires, Argentina
Sanatorio Duarte QuirosRecruiting
Córdoba, Argentina
Local Institution - 0069Not Yet Recruiting
Salta, Argentina
Centro de Investigaciones Clínicas Del Litoral SRLRecruiting
Santa Fe, Argentina
Hamilton General HospitalRecruiting
Hamilton, Ontario, Canada
Medicus MFC Inc.Recruiting
Toronto, Ontario, Canada
Local Institution - 0030Withdrawn
Toronto, Ontario, Canada
Local Institution - 0040Withdrawn
Toronto, Ontario, Canada
Local Institution - 0011Withdrawn
Montreal, Quebec, Canada
Local Institution - 0035Withdrawn
Trois-Rivières, Quebec, Canada
Peking Union Medical College Hospital - East CampusRecruiting
Beijing, Beijing Municipality, China
Guangdong Provincial People's HospitalRecruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan Science and Technology University - Jinghua CampusRecruiting
Luoyang, Henan, China
The Second Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China
The Second Affiliated Hospital, Zhejiang University School of Medicine - Jiefanglu CampusRecruiting
Hangzhou, Zhejiang, China
Local Institution - 0109Not Yet Recruiting
Jerusalem, Jerusalem, Israel
Local Institution - 0113Not Yet Recruiting
Jerusalem, Jerusalem, Israel
Local Institution - 0111Not Yet Recruiting
Beersheba, Israel
Local Institution - 0112Not Yet Recruiting
Be’er Ya‘aqov, Israel
Local Institution - 0108Not Yet Recruiting
Haifa, Israel
Local Institution - 0110Not Yet Recruiting
Petah Tikva, Israel
Local Institution - 0106Not Yet Recruiting
Rehovot, Israel
Local Institution - 0116Not Yet Recruiting
Safed, Israel
Local Institution - 0027Withdrawn
Foggia, Apulia, Italy
Local Institution - 0038Withdrawn
Foggia, Apulia, Italy
Local Institution - 0019Completed
Naples, Campania, Italy
Local Institution - 0023Withdrawn
Milan, Lombardy, Italy
Local Institution - 0033Withdrawn
Milan, Lombardy, Italy
IRCCS Policlinico San DonatoRecruiting
San Donato Milanese, Lombardy, Italy
Local Institution - 0050Withdrawn
San Donato Milanese, Lombardy, Italy
Local Institution - 0052Withdrawn
Massa, Tuscany, Italy
Local Institution - 0009Completed
Bergamo, Italy
Local Institution - 0017Completed
Pisa, Italy
Hyogo Prefectural Harima-Himeji General Medical CenterRecruiting
Himeji-Shi, Hyōgo, Japan
National Hospital Organization Kanazawa Medical CenterRecruiting
Kanazawa, Ishikawa-ken, Japan
Okayama Rosai HospitalRecruiting
Okayama, Okayama-ken, Japan
Kishiwada Tokushukai HospitalRecruiting
Kishiwada, Osaka, Japan
Takatsuki Red Cross HospitalRecruiting
Takatsuki-Shi, Osaka, Japan
Clinical Trials UMED Sp. z o.o.Recruiting
Lódz, Lódzkie, Poland
Local Institution - 0031Completed
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0044Withdrawn
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0020Withdrawn
Lublin, Woj. Lubelskie, Poland
Local Institution - 0049Withdrawn
Lublin, Woj. Lubelskie, Poland
Local Institution - 0006Withdrawn
Krakow, Poland
Local Institution - 0024Withdrawn
Oświęcim, Poland
Chungnam National University HospitalRecruiting
Daejeon, Daejeon Gwang'yeogsi, South Korea
Inha University HospitalRecruiting
Junggu, Incheon Gwang'yeogsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical CenterRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Pusan National University HospitalRecruiting
Busan, South Korea
Keimyung University Dongsan HospitalRecruiting
Daegu, South Korea
Chonnam National University HospitalRecruiting
Gwangju, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Local Institution - 0012Completed
L'Hospitalet de Llobregat, Barcelona, Spain
Local Institution - 0025Completed
Majadahonda, Madrid, Spain
Local Institution - 0047Withdrawn
Majadahonda, Madrid, Spain
Hospital Universitario Virgen de La ArrixacaRecruiting
El Palmar, Murcia, Spain
Local Institution - 0039Withdrawn
El Palmar, Murcia, Spain
Local Institution - 0042Withdrawn
Málaga, Málaga, Spain
Local Institution - 0026Completed
Madrid, Spain
Local Institution - 0034Withdrawn
Madrid, Spain
Local Institution - 0032Active Not Recruiting
Málaga, Spain
Hospital Nuestra Señora de ValmeRecruiting
Seville, Spain
Local Institution - 0046Withdrawn
Seville, Spain
Local Institution - 0010Completed
Valencia, Spain
Northwick Park HospitalRecruiting
Harrow, Greater London, United Kingdom
North Tyneside General HospitalRecruiting
North Shields, Northumberland, United Kingdom
Leeds General Infirmary - PPDSRecruiting
Leeds, Yorkshire, United Kingdom
Local Institution - 0057Withdrawn
Sheffield, Yorkshire, United Kingdom
Bristol Royal InfirmaryRecruiting
Bristol, United Kingdom
Local Institution - 0097Not Yet Recruiting
Dundee, United Kingdom
Local Institution - 0075Not Yet Recruiting
London, United Kingdom
John Radcliffe HospitalRecruiting
Oxford, United Kingdom
University Hospital of North TeesRecruiting
Stockton-on-Tees, United Kingdom
New Cross HospitalRecruiting
Wolverhampton, United Kingdom