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)
Status: Recruiting
Location: See all (117) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:
• \- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Colorado
Colorado Heart and Vascular - Lakewood
RECRUITING
Lakewood
Florida
Ascension St. Vincent's Riverside Hospital - PPDS
RECRUITING
Jacksonville
Local Institution - 0003
ACTIVE_NOT_RECRUITING
Miami
University of Miami FL Miller School of Medicine -1120 NW 14th St
RECRUITING
Miami
Georgia
Local Institution - 0014
WITHDRAWN
Atlanta
Local Institution - 0048
WITHDRAWN
Atlanta
Illinois
Bluhm Cardiovascular Institute of Northwestern
RECRUITING
Chicago
Chicago Medical Research, LLC - Hazel Crest
RECRUITING
Hazel Crest
Indiana
Ascension Medical Group St. Vincent - Indianapolis Heart Care
RECRUITING
Indianapolis
Local Institution - 0045
WITHDRAWN
Indianapolis
Missouri
Local Institution - 0043
WITHDRAWN
St Louis
St. Louis Heart and Vascular
RECRUITING
St Louis
North Carolina
Duke Cardiology Clinic - PPDS
RECRUITING
Durham
New Jersey
Local Institution - 0117
NOT_YET_RECRUITING
Hackensack
New York
Capital Cardiology Associates
RECRUITING
Albany
Local Institution - 0105
NOT_YET_RECRUITING
Brooklyn
Weill Cornell Medicine
RECRUITING
New York
Rochester General Hospital Center for Clinical Research
RECRUITING
Rochester
University of Rochester Medical Center - PPDS
RECRUITING
Rochester
Laurelton Heart Specialist PC - MyClinical - PPDS
RECRUITING
Rosedale
Ohio
Local Institution - 0058
WITHDRAWN
Cincinnati
Oklahoma
Local Institution - 0041
WITHDRAWN
Oklahoma City
South Oklahoma Heart Research
RECRUITING
Oklahoma City
Pennsylvania
Abington Memorial Hospital
RECRUITING
Abington
Tennessee
Tennessee Center for Clinical Trials
RECRUITING
Tullahoma
Texas
Local Institution - 0104
NOT_YET_RECRUITING
Austin
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Angiocardiac Care of Texas - PA - PPDS
RECRUITING
Houston
Local Institution - 0051
WITHDRAWN
Houston
Virginia
Local Institution - 0066
WITHDRAWN
Falls Church
Other Locations
Argentina
Centro de Especialidades Médicas CEMEDIC
RECRUITING
Buenos Aires
Local Institution - 0067
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0068
WITHDRAWN
Buenos Aires
Corporación Médica de General San Martín
RECRUITING
Ciudad Del Libertador General San Martín
Local Institution - 0053
NOT_YET_RECRUITING
Córdoba
Local Institution - 0090
NOT_YET_RECRUITING
Córdoba
Sanatorio Duarte Quiros
RECRUITING
Córdoba
Local Institution - 0073
NOT_YET_RECRUITING
Rosario
Local Institution - 0069
NOT_YET_RECRUITING
Salta
IPR-Investigaciones en Patologías Respiratorias
RECRUITING
San Miguel De Tucumán
Centro de Investigaciones Clínicas Del Litoral SRL
RECRUITING
Santa Fe
Local Institution - 0107
WITHDRAWN
Zárate
Local Institution - 0115
NOT_YET_RECRUITING
Zárate
Canada
Hamilton General Hospital
RECRUITING
Hamilton
Local Institution - 0011
WITHDRAWN
Montreal
Local Institution - 0030
WITHDRAWN
Toronto
Local Institution - 0040
WITHDRAWN
Toronto
Medicus MFC Inc.
RECRUITING
Toronto
Local Institution - 0035
WITHDRAWN
Trois-rivières
China
Peking Union Medical College Hospital - East Campus
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
The Second Affiliated Hospital, Zhejiang University School of Medicine - Jiefanglu Campus
RECRUITING
Hangzhou
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
RECRUITING
Luoyang
Israel
Local Institution - 0112
NOT_YET_RECRUITING
Be’er Ya‘aqov
Local Institution - 0111
NOT_YET_RECRUITING
Beersheba
Local Institution - 0108
NOT_YET_RECRUITING
Haifa
Local Institution - 0109
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0113
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0110
NOT_YET_RECRUITING
Petah Tikva
Local Institution - 0106
NOT_YET_RECRUITING
Rehovot
Local Institution - 0116
NOT_YET_RECRUITING
Safed
Italy
Local Institution - 0009
COMPLETED
Bergamo
Local Institution - 0027
WITHDRAWN
Foggia
Local Institution - 0038
WITHDRAWN
Foggia
Local Institution - 0052
WITHDRAWN
Massa
Local Institution - 0023
WITHDRAWN
Milan
Local Institution - 0033
WITHDRAWN
Milan
Local Institution - 0019
COMPLETED
Napoli
Local Institution - 0017
COMPLETED
Pisa
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Local Institution - 0050
WITHDRAWN
San Donato Milanese
Japan
Hyogo Prefectural Harima-Himeji General Medical Center
RECRUITING
Himeji-shi
National Hospital Organization Kanazawa Medical Center
RECRUITING
Kanazawa
Kishiwada Tokushukai Hospital
RECRUITING
Kishiwada
Okayama Rosai Hospital
RECRUITING
Okayama
Takatsuki Red Cross Hospital
RECRUITING
Takatsuki-shi
Poland
Local Institution - 0031
COMPLETED
Bialystok
Local Institution - 0044
WITHDRAWN
Bialystok
Local Institution - 0006
WITHDRAWN
Krakow
Clinical Trials UMED Sp. z o.o.
RECRUITING
Lódz
Local Institution - 0020
WITHDRAWN
Lublin
Local Institution - 0049
WITHDRAWN
Lublin
Local Institution - 0024
WITHDRAWN
Oświęcim
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Chungnam National University Hospital
RECRUITING
Daejeon
Chonnam National University Hospital
RECRUITING
Gwangju
Inha University Hospital
RECRUITING
Junggu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
Spain
Hospital Universitario Virgen de La Arrixaca
RECRUITING
El Palmar
Local Institution - 0039
WITHDRAWN
El Palmar
Local Institution - 0012
COMPLETED
L'hospitalet De Llobregat
Local Institution - 0026
COMPLETED
Madrid
Local Institution - 0034
WITHDRAWN
Madrid
Local Institution - 0025
COMPLETED
Majadahonda
Local Institution - 0047
WITHDRAWN
Majadahonda
Local Institution - 0032
ACTIVE_NOT_RECRUITING
Málaga
Local Institution - 0042
WITHDRAWN
Málaga
Hospital Nuestra Señora de Valme
RECRUITING
Seville
Local Institution - 0046
WITHDRAWN
Seville
Local Institution - 0010
COMPLETED
Valencia
United Kingdom
Bristol Royal Infirmary
RECRUITING
Bristol
Local Institution - 0097
NOT_YET_RECRUITING
Dundee
Northwick Park Hospital
RECRUITING
Harrow
Leeds General Infirmary - PPDS
RECRUITING
Leeds
Local Institution - 0075
NOT_YET_RECRUITING
London
North Tyneside General Hospital
RECRUITING
North Shields
John Radcliffe Hospital
RECRUITING
Oxford
Local Institution - 0057
WITHDRAWN
Sheffield
University Hospital of North Tees
RECRUITING
Stockton-on-tees
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2026-07-03
Participants
Target number of participants: 208
Treatments
Experimental: BMS-986435
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb