AURORA HFpEF - Clinical Trial
What is the 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.
Doctors are doing a study to test a new medicine called BMS-986435, also known as MYK-224. This medicine might help people who have a kind of heart problem called heart failure with preserved ejection fraction (HFpEF). That means their heart pumps normally but does not relax well, which can make it hard to breathe or feel active.
In the study:
- Adults with this heart problem will get either the real medicine or a fake one called a placebo.
- No one will know which one they are getting to keep the study fair.
- Doctors will check if the medicine is safe, if people can handle it well, and how it moves through the body.
- The study will last for a few years and include people from many places.
The goal is to see if this medicine can help people feel better and stay healthier.
Who Can Participate in the Study?
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
What is Involved?
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.
Study Details
