RecruitingPHASE3INTERVENTIONAL

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

The CONFIRMATION-HF study is investigating a new way to treat people who are in the hospital because of heart failure. It's comparing a combination of two medications, Finerenone and Empagliflozin, with the standard treatments patients usually receive. The main aim is to find out if this combination is more effective at helping patients with heart failure and if it's safe to use. Heart failure means your heart isn't pumping blood as well as it should, which can lead to symptoms like breathlessness and tiredness. This study hopes to find improved ways to manage this serious condition, helping patients recover and stay healthier. It's an important step in finding better treatments for heart failure.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Colorado Prevention Center

Enrolment target

1,500

Start

09 Jul 2024

Estimated completion

01 Nov 2027

Heart Failure

What is this study about?

Heart failure is a condition where your heart doesn't pump blood around your body as efficiently as it should. This can lead to symptoms like feeling very breathless, tired, and having swollen legs. When someone's heart failure gets worse, they might need to go into hospital for treatment.

This study, called CONFIRMATION-HF, is looking at a new treatment approach for people who are currently in hospital, or have just been discharged, because of heart failure. It brings together two medicines that are already used for other conditions: Finerenone and Empagliflozin. Researchers believe that using these two medicines together might be more effective than current standard treatments for heart failure.

The main goal of this study is to see if combining Finerenone and Empagliflozin is both safe and works better at helping patients recover from heart failure and preventing future problems. By carefully comparing this new combination with the usual care, doctors hope to find improved ways to help people living with heart failure lead healthier lives.

Key takeaways

Tests a new combination of two medicines for heart failure.
Aims to find better and safer treatments for hospitalised patients.
Involves regular check-ups and monitoring of your health.
Participation is voluntary, you can leave at any time.
Compared to usual care to see if it makes a difference.

Who may be eligible?

To join this study, you need to be at least 18 years old and either currently in the hospital, or have recently been discharged, because of heart failure. Your heart failure should have been the main reason for your hospital stay, and you should have been showing heart failure symptoms when you were admitted. Also, doctors will check your blood tests to make sure certain levels related to heart health are within a specific range.

You also need to have received at least one dose of a strong water tablet (called a loop diuretic) through a drip during your hospital stay. If you are a woman who could become pregnant, you'll need to confirm you're not pregnant and agree to use effective contraception throughout the study.

There are some reasons why you wouldn't be able to join. For example, if you've been diagnosed with type 1 diabetes, or have a history of a specific high potassium condition. You also can't join if you're already taking certain types of heart medications, or if your kidney function isn't within a particular range. Recent heart attacks, surgeries, or plans for a heart transplant would also mean you couldn't take part.

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 or older?
Were you recently in hospital for heart failure, or are you currently admitted for it?
Did you receive a strong water tablet through a drip during your hospital stay?
Do you have certain heart-related blood test levels, as confirmed by a doctor?
Are you able to use contraception if you are a woman who could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive the combination of Finerenone and Empagliflozin or continue with your usual heart failure care. Neither you nor your doctor will know which treatment group you are in, to keep the study fair and unbiased. You'll have regular hospital or clinic visits where doctors and nurses will monitor your health closely, take blood tests, and check how you're responding to treatment.

These visits will involve checks on your heart health, blood pressure, and overall well-being. The study wants to see how well the new treatment works over time. The total duration of your participation in the study will depend on the specific design, but it will involve ongoing follow-up to track your progress and safety.

Potential risks and benefits

Taking part in this study might mean you receive a new combination of medicines that could potentially improve your heart failure treatment beyond standard care. However, like all medicines, Finerenone and Empagliflozin can have side effects, and some might be serious. The study team will carefully monitor you for any such effects. It's important to remember that you can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (104)

CON-10004 Fairhope, AL Investigational Site
Verified postcode
Fairhope, United States· Recruiting
CON-10075 El Centro, CA Investigational Site
Verified postcode
El Centro, United States· Recruiting
CON-10024 Sacramento, CA Investigational Site
Verified postcode
Sacramento, United States· Recruiting
CON-10023, San Francisco, CA
Verified postcode
San Francisco, United States· Recruiting
CON-10109, Van Nuys, CA
Verified postcode
Van Nuys, United States· Recruiting
CON-10001, Aurora, CO
Verified postcode
Aurora, United States· Recruiting
CON-10005, Denver, CO
Verified postcode
Denver, United States· Recruiting
CON-10078, Hialeah, FL
Verified postcode
Hialeah, United States· Recruiting
CON-10105, Miami, FL
Verified postcode
Miami, United States· Recruiting
CON-10113, Miramar, FL
Verified postcode
Miramar, United States· Recruiting
CON-10022 Atlanta, GA Investigational Site
Verified postcode
Atlanta, United States· Recruiting
CON-10021, Glenview, IL
Verified postcode
Glenview, United States· Recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as strongly as it should, leading to symptoms like breathlessness and tiredness.

What are Finerenone and Empagliflozin?

These are two medicines already used for different conditions, and this study is testing them together for heart failure.

Will I know if I'm getting the new treatment?

No, to make the study fair, you won't know if you're getting the new combination or usual care.

How long will the study last?

The study will involve regular check-ups to monitor your health over time, but the exact total duration will be explained by the study team.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future 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.