MARITIME-HF - Clinical Trial
What is the Purpose of this Study?
In the first part of the study, some people will get a new medicine called maridebart cafraglutide. They will get small shots that slowly increase in amount over 16 weeks. Other people will get a fake medicine called a placebo, but the shots will look the same.
After this first part, people who stay in the study can join the second part. In this part, everyone will get the real medicine for about 2 years. Doctors will keep checking to see how well the medicine works and if it is safe.
This study is trying to find out if a new medicine called maridebart cafraglutide can help people who have heart failure and obesity. Heart failure means the heart does not work as well as it should. Obesity means having too much body fat, which can make heart problems worse.
The study includes people whose hearts still pump blood fairly well but have trouble filling with blood. These people often feel tired, short of breath, or have swelling in their legs.
Doctors want to see if this medicine can:
- Help people feel better
- Keep them out of the hospital
- Lower the chance of dying from heart problems
Some people in the study will get the real medicine, and others will get a fake one called a placebo. No one will know which one they are getting until the study is over. Everyone will still take their regular heart medicine.
The medicine is given as a shot once a month. The study will last for several years and include thousands of people. Doctors will check how the medicine affects the heart and how people feel during the study.
Who Can Participate in the Study?
To join the study, a person must:
- Be older than 18
- Have a body weight that is considered obese
- Have a heart that pumps more than 40% of its blood
- Never had a heart that pumped less than 40%
- Have a high level of a special substance in the blood that shows heart stress
- Also have at least one of these:
- A change in the shape or size of the heart
- Signs that the heart is having trouble filling with blood
- Been in the hospital for serious heart problems and needed strong medicine through a vein in the past year
What is Involved?
The study wants to show that the new medicine, maridebart cafraglutide, works better than a fake medicine (called a placebo). It is given along with regular heart care. Doctors will check if it helps people feel better and move more easily by reducing heart failure symptoms.
Study Details
