Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Launched by BRISTOL-MYERS SQUIBB · Nov 3, 2023
Trial Information
Current as of June 20, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new medication called BMS-986435/MYK-224 to see how safe it is and how well it works for people with heart failure who still have a normal heart pumping ability. Heart failure with preserved ejection fraction (HFpEF) means that the heart can pump normally, but the body still has symptoms like shortness of breath or fatigue. The study is currently recruiting adult participants who have stable, ongoing symptoms of HFpEF. However, those with certain heart conditions or serious illnesses that could interfere with the study won’t be eligible.
If you or a loved one participates in this trial, you can expect to receive the study medication and undergo regular assessments to monitor your health and how your body responds to the treatment. The goal is to gather important information about the safety and effects of this new drug, which could help improve treatment options for heart failure in the future.
Gender
ALL
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.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Valencia, , Spain
Malaga, , Spain
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Dallas, Texas, United States
Hamilton, Ontario, Canada
Madrid, , Spain
Hospitalet De Llobregat, Barcelona, Spain
Beijing, Beijing, China
Sevilla, , Spain
Oklahoma City, Oklahoma, United States
El Palmar, Murcia, Spain
New York, New York, United States
Houston, Texas, United States
Majadahonda, Madrid, Spain
Hazel Crest, Illinois, United States
Hangzhou, Zhejiang, China
Toronto, Ontario, Canada
Hazel Crest, Illinois, United States
Madrid, , Spain
Malaga, Málaga, Spain
San Donato Milanese, Lombardia, Italy
Oklahoma City, Oklahoma, United States
Tullahoma, Tennessee, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Saint Louis, Missouri, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Trois Rivieres, Quebec, Canada
Napoli, Campania, Italy
Melegnano, Lombardia, Italy
Milano, Lombardia, Italy
Milano, Lombardia, Italy
San Donato Milanese, Lombardia, Italy
Foggia, Puglia, Italy
Foggia, Puglia, Italy
Massa, Toscana, Italy
Pisa, Toscana, Italy
Lublin, Lubelskie, Poland
Bialystok, Podlaskie, Poland
Bialystok, Podlaskie, Poland
Lublin, , Poland
Oswiecim, , Poland
Majadahonda, Madrid, Spain
Majadahonda, Madrid, Spain
El Palmar, Murcia, Spain
Malaga, Málaga, Spain
A Gudina, Ourense, Spain
Madrid, , Spain
Murcia, , Spain
Sevilla, , Spain
Sevilla, , Spain
Krakow, , Poland
Miami, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Saint Louis, Missouri, United States
Oklahoma City, Oklahoma, United States
Houston, Texas, United States
Dallas, Texas, United States
Saint Louis, Missouri, United States
New York, New York, United States
Indianapolis, Indiana, United States
Bergamo, , Italy
Saint Louis, Missouri, United States
New York, New York, United States
Lódz, Lódzkie, Poland
Chicago, Illinois, United States
Hospitalet De Llobregat, Barcelona, Spain
Chicago, Illinois, United States
Pisa, Toscana, Italy
Bialystok, Podlaskie, Poland
Lublin, Woj. Lubelskie, Poland
Lublin, Woj. Lubelskie, Poland
Napoli, Campania, Italy
Pisa, Toscana, Italy
Dallas, Texas, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Montreal, Quebec, Canada
Bergamo, , Italy
Lódz, Lódzkie, Poland
Birmingham, Alabama, United States
Miami, Florida, United States
Hazel Crest, Illinois, United States
Tullahoma, Tennessee, United States
Houston, Texas, United States
General San Martín, Buenos Aires, Argentina
Córdoba, Cordoba, Argentina
Malaga, , Spain
Valencia, , Spain
Rochester, New York, United States
Cincinnati, Ohio, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
San Miguel De Tucumán, Tucuman, Argentina
Jung Gu, Incheon Gwang'yeogsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Harrow, Greater London, United Kingdom
Oxford, Oxfordshire, United Kingdom
Sheffield, Yorkshire, United Kingdom
Stockton On Tees, , United Kingdom
Wolverhampton, , United Kingdom
Albany, New York, United States
Falls Church, Virginia, United States
Rosario, Santa Fe, Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Salta, , Argentina
Pisa, , Italy
North Shields, Northumberland, United Kingdom
Leeds, Yorkshire, United Kingdom
Lakewood, Colorado, United States
Jacksonville, Florida, United States
Rochester, New York, United States
Rosedale, New York, United States
Durham, North Carolina, United States
Abington, Pennsylvania, United States
Córdoba, Cordoba, Argentina
Córdoba, , Argentina
Beijing, Beijing, China
Guangzhou, Guangdong, China
Luoyang, Henan, China
Changsha, Hunan, China
Hangzhou, Zhejiang, China
Himeji Shi, Hyogo, Japan
Okayama Shi, Okayama, Japan
Kishiwada, Osaka, Japan
Daegu, Daegu Gwang'yeogsi, Korea, Republic Of
Daejeon, Daejeon Gwang'yeogsi, Korea, Republic Of
Gwangju, Gwangju Gwang'yeogsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Busan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Dundee, , United Kingdom
London, , United Kingdom
Miami, Florida, United States
Santa Fe, , Argentina
Kanazawa, Ishikawa, Japan
Takatsuki Shi, Osaka, Japan
Seongnam Si, , Korea, Republic Of
Bristol, , United Kingdom
Brooklyn, New York, United States
Austin, Texas, United States
Zárate, Buenos Aires, Argentina
Rehovot, , Israel
Jung Gu, Incheon Gwang'yeogsi, Korea, Republic Of
Zárate, Buenos Aires, Argentina
Jerusalem, Yerushalayim, Israel
Jerusalem, Yerushalayim, Israel
Be'er Ya'akov, , Israel
Be'er Sheva, , Israel
Haifa, , Israel
Petah Tikva, , Israel
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported