RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists

This study is investigating a new medicine called Finerenone. It's for people who have heart failure with a reduced 'ejection fraction' – this means their heart doesn't pump blood as strongly as it should. The study aims to see if Finerenone is a safe and helpful treatment for these patients, especially if they can't use other existing heart failure medicines due to side effects or other reasons. Researchers will compare Finerenone to a placebo (a pill with no medicine) to understand its effects. This type of research helps doctors find new ways to improve the health and well-being of people living with heart failure.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Colorado Prevention Center

Enrolment target

2,600

Start

20 Aug 2024

Estimated completion

01 Apr 2028

Heart Failure

What is this study about?

This study is looking into a new medicine called Finerenone for people who have heart failure. Heart failure is a condition where your heart isn't pumping blood around your body as well as it should. The study focuses specifically on a type of heart failure where the heart's main pumping chamber (the left ventricle) doesn't squeeze as strongly as it should – doctors call this 'reduced ejection fraction'.

The main goal of this research is to see if Finerenone can help people with this type of heart failure to feel better and stay healthier. It's particularly important for patients who can't take other common heart failure medicines (such as spironolactone or eplerenone) because they might have had side effects, or their doctor has advised against them for other health reasons. By comparing Finerenone to a dummy pill (placebo), researchers can clearly see if any changes in health are due to Finerenone itself.

This is a 'Phase 3' trial, which means Finerenone has already been tested in smaller groups of people and shown some promise. It's also 'double-blind,' meaning neither the patients nor their doctors will know whether they are receiving Finerenone or the placebo. This helps make sure the study results are as fair and unbiased as possible. The information gathered from this study will help doctors understand if Finerenone could become a new treatment option for people with heart failure.

Key takeaways

Tests a new medicine (Finerenone) for heart failure.
Aimed at patients who can't use other standard treatments.
Compares Finerenone to a dummy pill (placebo).
Participation involves regular clinic visits and health checks.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you would generally need to be 18 years old or older and have been diagnosed with heart failure where your heart isn't pumping as strongly as it should. A key part of joining is that you must not be able to take certain other common heart failure medicines (called 'steroidal mineralocorticoid receptor antagonists') because of past side effects, or your doctor has said you shouldn't.

There are also some reasons why you wouldn't be able to join. For example, if you're already taking a similar new type of medicine, have very poor kidney function, or very high potassium levels. Also, if you've recently had a serious heart event like a heart attack or major surgery, or are planning to have a heart transplant, you might not be eligible. The study also wouldn't be right for you if your heart failure is caused by certain rare heart conditions or if you have other serious health issues that could interfere with the study.

For female participants, you would need to have a negative pregnancy test and agree to use effective contraception throughout the study. The medical team will check all these points carefully to make sure the study is safe and appropriate for you.

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 where your heart's pumping action is reduced?
Has your doctor told you that you can't take medicines like spironolactone or eplerenone?
Do you have good enough kidney function and safe potassium levels?
Are you able to attend regular clinic appointments for check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new medicine, Finerenone, or a dummy pill (placebo). Neither you nor your study doctor would know which one you're getting. You would take this study medicine regularly as instructed.

Throughout the study, you would have regular visits to the clinic. These visits would involve check-ups, blood tests to monitor your health (like kidney function and potassium levels), and other assessments to see how your heart failure is progressing and how you’re responding to the treatment. These visits are important for monitoring your safety and the effectiveness of the medicine. The total duration of your participation would depend on the study design, continuing as long as the researchers need to gather enough information about the effects of the treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, including access to a new medicine that could help your heart failure, especially if other treatments aren't suitable for you. You would also receive close medical attention and monitoring throughout the study. However, there are potential risks, as Finerenone is an investigational medicine, and its full effects are still being determined. You might experience side effects, or the medicine might not help your condition. The placebo could also mean your heart failure isn't actively treated with a new medicine during the study period. Your doctor will discuss all known potential risks and benefits with you in detail. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (8)

FIN-10004 Fairhope, AL Investigational Site
Verified postcode
Fairhope, United States· Recruiting
FIN-10075 San Diego, CA Investigational Site
Verified postcode
San Diego, United States· Recruiting
FIN-10002 Kansas City, MO Investigational Site
Verified postcode
Kansas City, United States· Recruiting
FIN-10015 Austin, TX Investigational Site
Verified postcode
Austin, United States· Recruiting
FIN-21003 Goiania, Goias Investigational Site
Verified postcode
Goiânia, Brazil· Recruiting
FIN-21049 Sao Paulo, Investigational Site
Unverified
Sao Paulp, Brazil· Recruiting
FIN-21004 Braganca Paulista, Investigational Site
Verified postcode
Bragança Paulista, Brazil· Recruiting
FIN-11012 Surrey, BC Investigational Site
Verified postcode
Surrey, Canada· Recruiting

Common questions

What is Finerenone?

Finerenone is a new medicine being tested for people with heart failure. It works differently from some existing treatments.

What is a 'placebo'?

A placebo is a dummy pill that looks like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects.

Who is this study for?

This study is for adults with a specific type of heart failure who cannot take other common heart failure medicines.

Will I know if I'm getting the real medicine?

No, neither you nor your doctor will know if you're receiving Finerenone or the placebo during the study. This helps keep the results fair.

What happens if I want to leave the study?

You can leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Marc Bonaca

info@cpcmed.org (303) 860-9900 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.