A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
This study is for children and young adults with heart failure where the left side of their heart isn't pumping blood effectively. It's looking into a new medicine called finerenone. Finerenone aims to help the heart work better by blocking a protein that can cause damage to the heart and blood vessels. Researchers want to understand how safe finerenone is and if it helps patients over a longer period when taken alongside their usual heart failure treatment. They will monitor participants closely for any medical problems, check blood pressure, kidney function, and blood potassium levels. This study includes babies, children, and young adults up to 18 years old.
At a glance
What is this study about?
Imagine your heart as a strong pump. In heart failure with left ventricular systolic dysfunction (LVSD), the main pumping chamber on the left side of the heart, called the left ventricle, struggles to pump blood effectively to the rest of your body. This can make people feel tired, short of breath, and in children, it might affect their growth. Doctors are always looking for better ways to help children and young adults with this condition, and that's where this study comes in.
The study is investigating a new medicine called finerenone, which is also sometimes known as Kerendia or BAY94-8862. This medicine is designed to block a specific protein in the body. This protein can cause inflammation, scarring, and thickening in the heart and blood vessels, which further weakens the heart's ability to pump. By blocking this protein, finerenone might help to protect the heart and improve its pumping action. The main goal of this particular study is to learn about how safe finerenone is and how well it helps patients over a longer period when added to the usual care they already receive for their heart condition.
This study is building on previous research and includes both participants who were part of an earlier finerenone study (called FIORE) and new, very young babies under 6 months old. Everyone taking part will continue to receive their standard medical care for heart failure, with finerenone being an additional treatment they take during the study. The researchers will be carefully checking for any side effects or medical problems, monitoring blood pressure, kidney health, and important blood levels, such as potassium.
Key takeaways
- This study is for children and young adults with a specific type of heart failure.
- It's testing a new medicine called finerenone to see if it's safe and effective.
- Participants will receive the new medicine alongside their usual heart failure treatment.
- The study involves regular visits for health checks and blood tests over 10-11 months.
- Close monitoring for potential side effects is a key part of the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you or your child would generally need to have heart failure where the left side of the heart isn't pumping strongly enough. This is called left ventricular systolic dysfunction (LVSD).
If you or your child were already in a previous study with finerenone (called FIORE) and completed it, you might be able to continue into this new study. For new babies under 6 months old, they would need to have specific findings on heart scans, certain blood test results, and be receiving standard care for their heart condition. They also need to weigh at least 3kg (about 6.5 pounds).
Some reasons why someone might not be able to join include having very high potassium levels in their blood. For those who were in the previous study, the potassium level that excludes them depends on whether they received finerenone or a dummy medicine (placebo) in the earlier study, and their age for those who took placebo.
- Do you or your child have heart failure where the left side of the heart is weak?
- If a baby, are they under 6 months old with specific heart problems and weighing at least 3kg?
- Are you or your child currently taking standard treatment for heart failure?
- Have you or your child had recent blood tests showing potassium levels within acceptable ranges for the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you or your child take part in this study, you'll be involved for about 10 to 11 months, depending on whether you're joining from a previous study or are a newly enrolled baby. You'll take the study medicine, finerenone, for up to 9 months of this time. During the study, you can expect to have at least 6 visits to the clinic.
At these visits, the study team will carry out several checks. This includes measuring your blood pressure, heart rate, temperature, breathing rate, height, and weight. Blood samples will be taken, and doctors will perform physical examinations. Your heart will be checked using an electrocardiogram (ECG), which records the electrical activity of your heart, and an echocardiogram, which is an ultrasound scan of your heart. You, or your parents/guardians, will also be asked questions about any medications you're taking and if you've experienced any medical problems. For babies taking part, parents will be asked for their feedback on how easy it is to give the study medicine.
After you take your last dose of the study medicine, the doctors will check on your health one month later to make sure everything is okay. You can withdraw from the study at any time if you change your mind.
Potential risks and benefits
Locations (132)
- Children's Hospital Colorado - Anschutz Medical Campus - CardiologyAurora, United States
- Nemours Children's Hospital - Delaware - CardiologyWilmington, United States
- UF Health Shands Hospital - Pediatric CardiologyGainesville, United States
- Joe Dimaggio Children's Hospital - CardiologyHollywood, United States
- Emory University Hospital - Children's Healthcare of Atlanta Cardiology - AtlantaAtlanta, United States
- Riley Hospital For Children - CardiologyIndianapolis, United States
- Boston Children's Hospital - Main Campus - CardiologyBoston, United States
- C.S. Mott Children's Hospital - CardiologyAnn Arbor, United States
- Children's Mercy Hospital Kansas City - CardiologyKansas City, United States
- Washington University - St. Louis Children's Hospital - CardiologySt Louis, United States
- Icahn School of Medicine at Mount Sinai - Pediatric CardiologyNew York, United States
- Columbia University Irving Medical Center - Pediatric CardiologyNew York, United States
+120 more sites — see the official record for the full list.
Common questions
What is heart failure with LVSD?
It's a condition where the main pumping chamber on the left side of your heart is weaker than it should be and struggles to pump blood effectively.
What is finerenone?
Finerenone is a new medicine being tested. It aims to help the heart by blocking a protein that causes damage and thickening in the heart and blood vessels.
How long will the study last?
The study will last around 10 to 11 months, and you'll take the study medicine for up to 9 months of that time.
What kind of tests will I have?
You'll have blood pressure checks, blood tests, physical exams, and heart scans like ECGs and echocardiograms.
Can I stop taking part if I want to?
Yes, absolutely. You can leave the study at any time you wish, and it won't impact your regular medical care.
How to find out more
Bayer Clinical Trials Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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