RecruitingPhase 2NCT06122779

Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

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)

Sponsor

Bristol-Myers Squibb

Enrollment

208 participants

Start Date

Nov 7, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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).

Eligibility

Min Age: 40 YearsMax Age: 85 Years

Inclusion Criteria1

\- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.

Exclusion Criteria1

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.

Interventions

DRUGBMS-986435

Specified dose on specified days

OTHERPlacebo

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

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

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

View Full Details on ClinicalTrials.gov

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