A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
This study is investigating a new medication, finerenone, for adults who have been hospitalised because their heart failure symptoms suddenly got worse. We're particularly interested in people whose hearts still pump a reasonable amount of blood (doctors call this 'mildly reduced or preserved ejection fraction'). Half the participants will receive finerenone, and the other half will receive a dummy pill (placebo). This helps us understand if finerenone is better than standard care at improving outcomes and safety for these patients. This is a common way to test new treatments, helping us find better ways to manage heart failure and improve patients' wellbeing.
At a glance
What is this study about?
This study is looking into a new medication called finerenone for people who have recently been admitted to hospital due to their heart failure symptoms getting worse. Heart failure means your heart isn't pumping blood around your body as efficiently as it should. There are different types of heart failure, and this study is focusing on individuals whose main heart pump (the left ventricle) can still push out a reasonable amount of blood – doctors might describe this as 'mildly reduced' or 'preserved' ejection fraction.
The main aim of this research is to see if finerenone is safe and effective in helping these patients. We want to find out if it can reduce the chances of health problems, improve how patients feel, and potentially help them live longer and healthier lives after experiencing a heart failure episode. By comparing finerenone with a dummy pill, we can clearly see if any improvements are due to the new drug itself.
Taking part in a study like this is crucial because it helps us gather important information about new medicines. This information ensures that new treatments, if effective, can be made available to more people in the future, ultimately improving care for those living with heart failure. All participants will be closely monitored by a medical team throughout the study to ensure their safety and well-being.
Key takeaways
- Tests finerenone for heart failure patients recently hospitalised.
- Focuses on patients whose heart can still pump blood fairly well.
- Compares finerenone against a dummy pill (placebo) to check effectiveness and safety.
- Aims to improve patient outcomes and quality of life.
- Close medical monitoring throughout the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you generally need to be an adult (18 or over) who has recently been in hospital, or is currently in hospital, because your heart failure symptoms worsened. Doctors will need to confirm your heart failure diagnosis and that your heart is still pumping blood fairly well (this is often checked with imaging like an ultrasound scan of your heart). We'll also check your blood for certain markers related to heart strain.
There are also some reasons why you might not be able to join. For example, if you're already taking a similar type of heart medication called an MRA, or if you've had certain kidney problems or very high potassium levels in the past. We also can't include people who have had certain severe heart events, specific types of heart valve problems, or particular other heart conditions in the last month. We'll also need to check if you're taking any other medications that might interfere with the study drug.
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?
- Have you recently been in hospital (or are you currently there) because of worsening heart failure?
- Has a doctor told you that your heart's pumping ability (ejection fraction) is 40% or more?
- Are you NOT currently taking a similar heart medicine called an 'MRA'?
- Do you NOT have severe kidney problems or very high potassium levels?
- Have you NOT had a heart attack, major heart surgery, or valve repair in the last month?
What does participation involve?
If you decide to take part, you'd be randomly assigned to either receive the new drug (finerenone) or a dummy pill (placebo); you and your doctors wouldn't know which one you're getting. You would take this medication regularly. You’d need to attend several study visits for health checks, blood tests, and to make sure the treatment is safe and working well. The total duration of the study would depend on how your health progresses, but it typically involves regular follow-up over a period of time to fully assess the long-term effects of the treatment.
Potential risks and benefits
Locations (299)
- Birmingham, AL Investigative Site 10012Verified postcodeBirmingham, United States· Recruiting
- Fairhope, AL Investigative Site 10004Verified postcodeFairhope, United States· Recruiting
- Huntsville, AL Investigative Site 10026Verified postcodeHuntsville, United States· Recruiting
- Glendale, AZ Investigative Site 10096Verified postcodeGlendale, United States· Recruiting
- Scottsdale, AZ Investigative Site 10003Verified postcodeScottsdale, United States· Recruiting
- Chula Vista, CA Investigative Site 10111Verified postcodeChula Vista, United States· Recruiting
- Huntington Beach, CA Investigative Site 10031Verified postcodeHuntington Beach, United States· Recruiting
- Los Angeles, CA Investigative Site 10089Verified postcodeLos Angeles, United States· Recruiting
- Sacramento, CA Investigative Site 10024Verified postcodeSacramento, United States· Recruiting
- San Francisco, CA Investigative Site 10023Verified postcodeSan Francisco, United States· Recruiting
- Tarzana, CA Investigative Site 10409Verified postcodeTarzana, United States· Recruiting
- Van Nuys, CA Investigative Site 10109Verified postcodeVan Nuys, United States· Recruiting
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood around your body as efficiently as it should. It's a long-term condition that can lead to symptoms like breathlessness and tiredness.
What does 'Ejection Fraction' mean?
Ejection fraction is a measurement of how well your heart's main pumping chamber (the left ventricle) squeezes blood out with each beat. This study is for people whose ejection fraction is 40% or higher, meaning their heart is still pumping a reasonable amount of blood.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers compare the real drug's effects to no treatment, giving a clearer picture of its benefits.
Will I know if I'm getting the active drug or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know whether you are receiving finerenone or the placebo. This helps ensure the study results are fair and unbiased.
Can I leave the study at any time?
Yes, your participation is completely voluntary. You can withdraw from the study at any time, for any reason, without affecting your regular medical care.
How to find out more
Marc Bonaca
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.