Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
This study is testing a new medicine called Maridebart cafraglutide for people who have a type of heart failure where their heart's pumping action is either normal or only slightly weaker, and who also have obesity. We want to find out if this new medicine, when added to the care they already receive, can help reduce serious heart events like needing to go to hospital. The study also investigates if it can improve how people feel and reduce the risk of dying from heart-related causes. This is a large, international study with a double-blind phase, meaning neither you nor your doctor will know if you're getting the new medicine or a dummy treatment, followed by an open-label period where everyone gets the active medicine.
At a glance
What is this study about?
Heart failure is a condition where your heart can't pump enough blood around your body. This study focuses on people with specific types of heart failure: "heart failure with preserved ejection fraction" (HFpEF) and "heart failure with mildly reduced ejection fraction" (HFmrEF). This means your heart is still pumping blood quite well, or only slightly less effectively, but it's not working as efficiently as it should.
Alongside heart failure, this study is for individuals who also have obesity. Obesity can put extra strain on the heart, so researchers want to see if a new medicine, Maridebart cafraglutide, can make a difference for people facing both these health challenges. The main goal is to see if this medicine can help prevent worsening heart failure, reduce the need for hospital visits for heart problems, make you feel better, and ultimately, help you live longer.
This is a large-scale study that involves many people across different countries. It's organised into two main parts: an initial period where some people get the new medicine and others get a placebo (a dummy treatment), and then a second period where everyone knows they are receiving the study medicine. This careful testing helps doctors understand if the new medicine is both safe and effective in improving the health of people with heart failure and obesity.
Key takeaways
- This study is for adults with a specific type of heart failure and obesity.
- It tests a new medicine called Maridebart cafraglutide to improve heart health.
- Participation involves taking either the new medicine or a placebo first.
- You'll have regular medical checks and follow-up appointments.
- The goal is to reduce hospital stays and improve how you feel.
Who may be eligible?
You might be able to take part in this study if you are 18 years or older and have been diagnosed with heart failure for at least a month. Your heart failure needs to be stable and you should be receiving standard care for it. Importantly, your heart's main pumping chamber must be working reasonably well (with an ejection fraction of more than 40%) and you need to have a BMI (Body Mass Index) of 30 or higher, which means you have obesity.
To be considered, you would also need to show some signs of heart strain, like certain blood test results or a history of heart problems such as structural heart disease, a previous hospital stay for worsening heart failure, or evidence of high pressure in your heart.
There are also some reasons why you might not be able to join. For instance, if you've had a recent heart attack, heart surgery, or a stroke within the last two months. Certain other heart conditions, type 1 diabetes, or poorly controlled type 2 diabetes could also prevent your participation. The study staff will carefully check all these details to see if you're a good fit.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have heart failure with your heart pumping normally or only slightly weaker?
- Do you have a BMI of 30 or more (meaning you have obesity)?
- Have you been receiving standard treatment for your heart failure?
- Have you *not* had a heart attack, stroke, or heart surgery in the last 2 months?
What does participation involve?
If you join this study, you will be assigned to either receive the new study medicine, Maridebart cafraglutide, or a placebo (a dummy medicine) for a period. Neither you nor your doctor will know which one you are getting at this stage. After this initial period, you will then receive the actual study medicine in an 'open-label' phase, where everyone knows what treatment they are taking.
Taking part will involve regular visits to the study clinic for check-ups, blood tests, and to assess your heart health and symptoms. These visits will help the doctors monitor how you are responding to the treatment and ensure your safety. You will also be asked questions about how you are feeling and any side effects you might experience. The total duration of your participation will depend on how the study progresses, as it will continue until a certain number of key heart-related events have occurred across all participants. You can expect to be followed by the study team for an extended period.
Potential risks and benefits
Locations (628)
- University of Alabama Saint Vincent's BirminghamVerified postcodeBirmingham, United States· Recruiting
- SEC Clinical ResearchVerified postcodeDothan, United States· Recruiting
- Eastern Shore Research InstituteVerified postcodeFairhope, United States· Recruiting
- Heart Center Research LLCVerified postcodeHuntsville, United States· Recruiting
- HonorHealthVerified postcodePhoenix, United States· Recruiting
- Medical Advancement Centers of ArizonaVerified postcodePhoenix, United States· Recruiting
- Pima Heart and Vascular Clinical ResearchVerified postcodeTucson, United States· Recruiting
- Yuma Clinical TrialsVerified postcodeYuma, United States· Recruiting
- Arkansas CardiologyVerified postcodeLittle Rock, United States· Recruiting
- National Heart InstituteVerified postcodeBeverly Hills, United States· Recruiting
- Valley Clinical Trials, LLC dba Flourish ResearchVerified postcodeCovina, United States· Recruiting
- National Institute of Clinical ResearchVerified postcodeHuntington Beach, United States· Recruiting
Common questions
What is 'ejection fraction'?
Ejection fraction is a measurement that tells us how much blood your heart pumps out with each heartbeat. In this study, it refers to your heart pumping blood either normally or only slightly weaker.
What does 'obesity' mean in this study?
In this study, obesity means having a Body Mass Index (BMI) of 30 or higher. BMI is a measure that uses your height and weight to see if you're a healthy weight.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps doctors see if the study medicine really works better than no treatment at all.
What are 'HF events'?
HF events are serious heart-related problems, such as needing to go to the hospital because your heart failure has worsened, or urgent visits to the doctor for heart failure symptoms.
Will I have to pay to participate?
No, you will not have to pay to participate in the study. All study-related medicines, tests, and medical care will be provided by the study.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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