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RecruitingPHASE3INTERVENTIONAL

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

This study aims to discover if a new combination of medicines, vicadrostat and empagliflozin, can help adults living with heart failure. We're inviting people aged 18 and over who have heart failure with symptoms and a heart pumping ability (LVEF) of 40% or more. Participants will be randomly assigned to one of two groups: one receiving the new combination of medicines, and the other receiving a dummy pill (placebo) alongside empagliflozin. Everyone takes tablets once a day. The study doesn't have a fixed end date; it will continue until enough information is gathered to understand if the treatment is effective. Throughout the study, participants will have regular check-ups with doctors and answer questions about their well-being, with their health and any side effects carefully monitored.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Boehringer Ingelheim
Enrolment target
6,000
Start
17 Jun 2024
Estimated completion
22 May 2028

What is this study about?

Heart failure is a serious condition where your heart can't pump enough blood around your body. This study is testing a new approach for people who have a specific type of heart failure where their heart can still pump reasonably well, meaning the left pumping chamber (ventricle) empties 40% or more of its blood with each beat. We want to see if combining a new medicine called vicadrostat with an existing medicine called empagliflozin can help these individuals.

Empagliflozin is already used for some people with heart failure, and this study aims to understand if adding vicadrostat makes the treatment even more effective. The study is particularly looking for adults aged 18 and over who have symptoms of heart failure and this specific heart pumping ability. By taking part, you'd be helping doctors learn more about managing heart failure, which could benefit many people in the future.

Participants will be placed into one of two groups by chance – like flipping a coin. One group will receive the new medicine combination (vicadrostat and empagliflozin), and the other will receive a dummy pill (a placebo) along with empagliflozin. This allows researchers to compare the effects of the new combination against the existing treatment. Everyone will take their study medication as tablets once a day, and their health will be carefully watched.

Key takeaways

  • This study evaluates a new treatment for a specific type of heart failure.
  • It combines two medicines: vicadrostat and empagliflozin.
  • Participants take daily tablets and are regularly monitored by doctors.
  • You might receive the active treatment or a placebo alongside empagliflozin.
  • Participation helps advance understanding of heart failure treatment.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with chronic heart failure for at least three months. To join, your heart failure symptoms should fall into certain categories (NYHA Class II-IV), and your heart's main pumping chamber should be able to empty at least 40% of its blood with each beat (this is called your LVEF).

You'll also need to show signs of structural changes in your heart, such as a thicker heart wall or an enlarged upper heart chamber, which can be seen on heart scans. Additionally, a specific blood test called NT-proBNP needs to show elevated levels, which can be an indicator of heart strain.

If you are a woman who could become pregnant, you would need to use highly effective birth control throughout the study. All participants must be willing and able to sign a consent form, showing you understand what taking part involves.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with heart failure for at least 3 months?
  3. Do you have current symptoms of heart failure?
  4. Has your heart's main pumping chamber (LVEF) been measured at 40% or more?
  5. Do you have signs of structural changes in your heart seen on a scan?
  6. Are you a woman who could get pregnant and willing to use effective birth control?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given tablets to take once a day. These will either be the new combination of vicadrostat and empagliflozin, or a dummy pill (placebo) along with empagliflozin. You won't know which group you are in, and neither will your study doctor, as this helps make the results fairer.

You will have regular appointments with your doctors at a clinic. They will check your health, including your heart, and record any changes or side effects you might experience. Study staff may also call you occasionally to check in. You'll also be asked to complete questionnaires about how you are feeling and your overall well-being. The study doesn't have a set end date for each participant; you can continue as long as the treatment is helping you and you can tolerate it, and until the researchers have gathered enough information to understand if the treatment works for everyone involved.

Potential risks and benefits

Taking part in a clinical study could offer potential benefits, such as contributing to medical knowledge that might help others with heart failure in the future, and receiving close medical monitoring. However, there are also potential risks, including side effects from the medications, which will be carefully monitored by the study team. You might also receive a placebo, meaning you wouldn’t get the active new treatment. Your participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (651)

  • Diagnostic and Medical Clinic
    Verified postcode
    Mobile, United States· Not yet recruiting
  • Mobile Heart Specialists, PC
    Verified postcode
    Mobile, United States· Recruiting
  • Velocity Clinical Research-Chula Vista
    Verified postcode
    Chula Vista, United States· Recruiting
  • University of California Irvine
    Verified postcode
    Orange, United States· Not yet recruiting
  • North America Research Institute
    Verified postcode
    San Dimas, United States· Recruiting
  • Amicis Research Center - Valencia
    Verified postcode
    Santa Clarita, United States· Recruiting
  • Orange County Research Center
    Verified postcode
    Tustin, United States· Recruiting
  • Bridgeport Hospital
    Verified postcode
    Bridgeport, United States· Not yet recruiting
  • Excel Medical Clinical Trials
    Verified postcode
    Boca Raton, United States· Recruiting
  • Bay Area Cardiology
    Verified postcode
    Brandon, United States· Recruiting
  • Clearwater Cardiovascular and Interventional Consultants
    Verified postcode
    Clearwater, United States· Recruiting
  • Cardiology Associates Research Co.
    Verified postcode
    Daytona Beach, United States· Recruiting

Common questions

What is heart failure?

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

What does 'LVEF' mean?

LVEF stands for Left Ventricular Ejection Fraction. It's a measurement that tells us how much blood your heart's main pumping chamber pushes out with each beat.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the real medicine.

How long will I be in the study?

The study doesn't have a fixed length for each person. You can stay in as long as you benefit and tolerate the treatment, and until enough information is collected overall.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and it will not affect your routine medical care.

How to find out more

Boehringer Ingelheim

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Test Whether Vicadrostat in Combination With Empa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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