A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy
This research study is looking into a new medicine called CDR132L for people who have heart failure. Heart failure means your heart isn't pumping blood as well as it should. The study wants to understand how CDR132L might change the way the heart looks and works. Participants in the study will be split into two groups by chance: one group will receive CDR132L, and the other will receive a placebo – a dummy pill that contains no active medicine. This helps researchers fairly compare the effects of the new medicine. The study will last for around 60 weeks, giving researchers enough time to observe any changes. This type of study helps us learn more about new treatments that could improve the health of people with heart failure.
At a glance
What is this study about?
Heart failure is a condition where your heart muscle can't pump enough blood around your body to meet its needs. This study is focusing on a specific type of heart failure where the heart's main pumping chamber (the left ventricle) doesn't squeeze as strongly as it should, and its walls might also be thicker than normal. Researchers believe this new medicine, called CDR132L, might help improve how the heart works and change its structure for the better.
To find out if CDR132L works, scientists need to test it carefully. That's why they are running this clinical trial. Some participants will be given CDR132L, while others will receive a placebo, which looks exactly like the study medicine but has no ingredients that affect the body. Deciding who gets which treatment is done completely by chance, like flipping a coin. This helps make sure the study results are fair and reliable, so we can be confident about the medicine's effects.
The study will last for about 60 weeks, which is a little over a year. During this time, the research team will keep a close eye on the participants, doing various checks and tests to see if CDR132L has any positive (or negative) effects on the heart. By understanding how this new medicine works, we hope to find better ways to help people living with heart failure.
Key takeaways
- This study is testing a new medicine (CDR132L) for a type of heart failure.
- It aims to see how the medicine affects the heart's structure and function.
- Participants will receive either the new medicine or a dummy pill (placebo) by chance.
- The study lasts for about 60 weeks with regular check-ups.
- It's for people with stable heart failure, aged 40-84, with specific heart conditions.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, participants must be between 40 and 84 years old. You need to have been diagnosed with heart failure for at least six months and still be taking water tablets (diuretics) weekly for your symptoms. Your heart failure should also be stable and managed with your usual medicines for at least 45 days before starting the study.
The study is specifically looking for people whose hearts aren't pumping blood as strongly as they should (less than 50% efficiency) and whose heart muscle is thicker than normal or whose heart has become enlarged. Your weight and body mass index (BMI) also need to be within a certain range. Finally, a specific blood test called NT-proBNP must show levels indicating heart strain, with slightly higher levels allowed if you also have an irregular heartbeat called atrial fibrillation.
People cannot join the study if they have severe kidney problems (where their kidneys filter blood very slowly) or if they've recently had a sudden and severe kidney issue, as decided by the study doctor.
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 between 40 and 84 years old?
- Have you been diagnosed with heart failure for at least 6 months and still need water tablets every week?
- Is your heart failure stable and managed with your current medicines?
- Has your heart's main pumping chamber (left ventricle) been shown to pump less than 50% efficiently by a scan?
- Has a scan shown your heart muscle is thicker than normal or your heart is enlarged?
- Are your kidneys generally healthy (not severe kidney disease)?
What does participation involve?
If you decide to take part in this study, you will first go through a screening process to make sure you fit all the requirements. This will involve physical exams, blood tests, and heart scans (like an echocardiogram) to check your heart's health and function. Once you're confirmed eligible, you would then be randomly assigned to either receive the new medicine, CDR132L, or a placebo, which looks identical but has no active ingredients. Neither you nor your study doctor will know which one you are receiving.
Throughout the study, which lasts about 60 weeks (just over a year), you will have regular visits to the clinic. At these visits, the study team will monitor your health closely, repeat blood tests, and conduct more heart scans to see how your heart is responding to the treatment. You will be given the study medication to take at home as instructed. These visits are important for the researchers to collect information and ensure your safety. All study-related medical care and medicines will be provided at no cost, and you will be fully supported by the medical team during your participation.
Potential risks and benefits
Locations (92)
- Concord Repatriation General Hospital - Cardiology DepartmentVerified postcodeConcord, Australia· Recruiting
- The Prince Charles HospitalVerified postcodeBrisbane, Australia· Not yet recruiting
- Royal Adelaide Hospital - Cardiology DepartmentVerified postcodeAdelaide, Australia· Recruiting
- Flinders Medical CentreVerified postcodeBedford Park, Australia· Recruiting
- Royal Hobart HospitalVerified postcodeHobart, Australia· Recruiting
- Victorian Heart HospitalVerified postcodeClayton, Australia· Recruiting
- Fiona Stanley Hospital - CardiologyVerified postcodeMurdoch, Australia· Recruiting
- Fakultní nemocnice u sv. Anny v BrněVerified postcodeBrno, Czechia· Completed
- Nemocnice České Budějovice a.s.Verified postcodeČeské Budějovice, Czechia· Recruiting
- Fakultní Nemocnice OstravaUnverifiedOstrava-Poruba, Czechia· Recruiting
- Vseobecna fakultni nemocnice v PrazeVerified postcodePrague, Czechia· Recruiting
- Pratia Prague, s.r.oVerified postcodePrague, Czechia· Not yet recruiting
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood around your body as well as it should. It doesn't mean your heart has stopped working, but it can make you feel tired and breathless.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It's used in studies to help researchers compare the effects of the new medicine fairly.
How long will the study last?
The study will last for about 60 weeks, which is a little over a year, during which you'll have regular check-ups and take the study medicine.
Will I know if I'm getting the new medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving CDR132L or the placebo. This helps ensure the study results are unbiased.
Are there costs involved for me?
No, all study-related medical care, tests, and medicines will be provided at no cost to you.
How to find out more
Novo Nordisk
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.