Purpose of this Study
This study is testing a new medicine called MYK-224 to help people with a heart problem called HFpEF. That means their heart pumps well but does not relax properly. People in the study also have signs that their heart is not working normally.
The study has four groups, called cohorts. Duke is only helping with Cohort 4, which will include about 160 people. These people will be split into four smaller groups. Three groups will get different amounts of the real medicine, and one group will get a fake medicine called a placebo.
The treatment will last 20 weeks. A special team of doctors will check to make sure the medicine is safe and decide how much each group should get.
To join the study, people must meet certain health rules.
Who Can Participate?
Eligibility
To join this part of the study, a person must:
- Have a heart that pumps well (55% or more), but still has heart problems
- Feel symptoms like tiredness or trouble breathing (NYHA Class II or III)
- Have signs that their heart is not working normally, like thick walls or a large upper chamber
- Have high levels of certain heart chemicals that show stress
- Be between 40 and 85 years old
- Have a clear heart picture from an ultrasound test
- Already be diagnosed with this kind of heart problem, based on doctor guidelines
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
Some people with a heart problem called HFpEF still feel sick even when they take the right medicine. They get tired easily, cannot exercise much, and may need to go to the hospital.
Doctors are testing a new medicine called MYK-224. It works by helping the heart relax better and use less energy. This may help the heart work more smoothly and make people feel better.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full 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)
Principal Investigator
Marat
Fudim
Protocol Number
PRO00118065
NCT ID
NCT06122779
Phase
II
Enrollment Status
Pending Open to Enrollment