Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (≤ 45%) After Myocardial Infarction (HF-REVERT)
This research study, called HF-REVERT, is testing a new medication called CDR132L. It's for people who have recently had a heart attack and, as a result, their heart's main pumping chamber (left ventricle) isn't working as strongly as it should. The main goal is to find out if this new medication helps improve the heart's pumping ability and if it's safe. Participants will be split into different groups – some will receive the new medication and some will receive a 'dummy' treatment (placebo) – to compare the effects. Doctors will monitor heart function, general health, and any side effects over several months.
At a glance
What is this study about?
Imagine your heart as a powerful pump. After a heart attack, sometimes this pump can become weaker, making it harder for your heart to send blood around your body effectively. This is often called 'heart failure' or a 'reduced ejection fraction' by doctors. This study is testing a new medication, CDR132L, to see if it can help improve the heart's strength and overall function after a heart attack.
Researchers want to see if this new medication can help the heart muscle recover and improve how well it squeezes. They'll be looking closely at detailed scans of the heart to measure its size and how effectively it pumps blood. They also want to make sure the medication is safe and doesn't cause too many unwanted side effects. Finding new ways to help hearts recover after an attack is really important for people's long-term health and quality of life.
This is a 'Phase 2' study, which means it's one of the earlier steps in testing a new treatment. It helps doctors understand more about how the medication works, what dose might be best, and if it's promising enough to continue with larger studies in the future. By participating, you could help scientists learn crucial information that might benefit many people who experience heart attacks.
Key takeaways
- Tests a new medication (CDR132L) for weakened hearts after a heart attack.
- Compares the new drug to a 'dummy' treatment (placebo).
- Aims to improve heart function and ensure safety.
- Involves regular check-ups, heart scans, and blood tests over 12 months.
- Participants are adults who recently had a heart attack and have reduced heart function.
Who may be eligible?
This study is looking for adult men and women, aged 18 and over, who have recently had a heart attack. After the heart attack, their heart's main pumping chamber (the left ventricle) must be shown to be weaker than normal, meaning it doesn't pump blood as strongly as it should. This will be checked with a special heart scan.
To be considered, your heart attack and the first screening check for the study must have happened within a specific time window – the screening needs to take place between 3 and 14 days after your heart attack diagnosis. This helps ensure that the medication is tested at a key time for heart recovery.
There will be other medical criteria that a doctor will check to make sure the study is safe and appropriate for you, such as your general health, other medications you are taking, and any other medical conditions you might have. You won't be able to join if you have certain existing health problems or if the study medication might interfere with other treatments.
- Are you 18 years old or older?
- Have you had a heart attack recently (within the last 14 days)?
- Has your doctor told you that your heart's pumping is weaker than normal after your heart attack?
- Are you able to attend regular clinic appointments for about a year?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of several groups. You might receive the new study medication (CDR132L), which is given as an injection, or a 'dummy' injection (placebo) that looks identical but contains no active medicine. Neither you nor your study doctor will know which you are receiving, which helps ensure fair results.
You will have several visits to the clinic over roughly 12 months. During these visits, doctors will perform heart scans (echocardiograms) to check your heart's function, take blood and urine samples, measure your vital signs (like blood pressure and heart rate), perform physical examinations, and check your heart's electrical activity with an ECG. You'll also be asked questions about how you are feeling, your symptoms, and your general well-being.
Regular follow-up appointments are important to monitor your health, how the treatment is affecting you, and any potential side effects. The total duration of active treatment and follow-up will be about 12 months from when you join the study.
Potential risks and benefits
Locations (7)
- —Poland
- —Spain
- —Czechia
- —Greece
- —Netherlands
- —Germany
- —Hungary
Common questions
What is a 'heart attack' in this study?
A heart attack happens when blood flow to part of the heart muscle is blocked, causing damage. This study is for people who have recently had one.
What does 'weakened heart pumping' mean?
It means your heart's main chamber (left ventricle) isn't squeezing as strongly as it should, making it harder to pump blood around your body effectively.
Will I definitely get the new medication?
No, you will be randomly assigned to either receive the new medication or a 'dummy' treatment (placebo). It's like flipping a coin.
How long will I be in the study?
You'll be involved for about 12 months, including regular clinic visits for check-ups and tests.
What are heart scans (echocardiograms) for?
These are special ultrasound scans that allow doctors to look at your heart's structure and how well it's pumping, safely and without radiation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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