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Not yet recruitingPHASE3INTERVENTIONAL

SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

This study is for adults with a heart condition called Fontan Circulatory Failure (FCF). This condition happens to some people born with only one main pumping chamber in their heart. While surgery (the Fontan operation) can help, over time, the heart might not pump as well, leading to FCF. This can make daily activities challenging. Currently, a heart transplant is the only long-term solution. Researchers are now testing if a medication called empagliflozin can improve the quality of life for people with FCF. Participants will take either empagliflozin or a dummy pill (placebo) for 12 weeks, alongside their usual care, to see if it makes a difference.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
Subodh Verma
Enrolment target
410
Start
01 May 2025
Estimated completion
01 Mar 2028
Congenital Heart Disease

What is this study about?

Some people are born with a special type of heart condition where they only have one main pumping chamber (ventricle) instead of the usual two. To help these children, doctors perform an operation called the Fontan procedure. This surgery helps the blood flow better, but over many years, the single pumping chamber can sometimes struggle to keep up with the body's needs. When this happens, it's called Fontan Circulatory Failure (FCF).

Living with FCF can make everyday activities like walking or exercising feel very difficult because the heart can't deliver enough oxygen and nutrients where they're needed. Right now, a heart transplant is the only lasting treatment option. However, doctors are always looking for new ways to help people with FCF manage their symptoms and improve their quality of life without needing such a major operation.

This study is looking at a medication named empagliflozin. This drug is already used for other heart conditions and diabetes. Researchers want to find out if it can help adults with FCF feel better, have more energy, and improve their ability to do daily tasks. They will compare empagliflozin to a 'dummy' pill (called a placebo) to see if the drug really makes a difference.

Key takeaways

  • This study is testing a drug called empagliflozin for Fontan Circulatory Failure (FCF).
  • FCF makes everyday activities hard because the heart struggles to pump enough blood.
  • Currently, a heart transplant is the main treatment for advanced FCF.
  • The study aims to see if empagliflozin can improve quality of life for adults with FCF.
  • Participants will take either the drug or a dummy pill for 12 weeks.
  • Close monitoring by doctors and nurses will happen regularly during the study.

Who may be eligible?

This study is looking for adults aged 18 or over who have Fontan Circulatory Failure (FCF). This means your Fontan heart physiology is causing difficulties with your daily activities, and you are already receiving standard medical care for your condition.

There are also some reasons why you might not be able to join. For example, if you've recently started or changed certain heart medications, are currently taking another SGLT2 inhibitor, or have had certain medical procedures or hospital stays very recently. If you are pregnant, planning to become pregnant, or breastfeeding, you cannot join. People with Type 1 diabetes, certain uncontrolled illnesses, severe kidney or liver problems, or very high or very low blood pressure are also not eligible.

It's important that you don't have any planned hospital treatments for your FCF during the study period, or any thoughts of having major heart procedures soon. You also need to be able to fully understand the study and follow all the instructions.

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. Do you have Fontan Circulatory Failure (FCF) that affects your daily life?
  3. Are you currently receiving standard medical care for your FCF?
  4. Are you free from Type 1 diabetes and certain severe kidney/liver problems?
  5. Are you NOT pregnant, planning pregnancy, or breastfeeding?
  6. Have you NOT recently had changes to specific heart medications or major heart procedures?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a screening visit to check if you're suitable. If you are, you'll be assigned by chance to either receive the study drug, empagliflozin (10 mg once a day), or a dummy pill (placebo) once a day. You won't know which one you're taking, and neither will your doctor – this is a 'blinded' study.

The study treatment period lasts for 12 weeks. During these 12 weeks, you will have four in-person visits at the study clinic and three check-up calls from the study team. These calls might be by phone or video. These visits and calls are designed to monitor your health, how you're feeling, and if there are any changes. The total duration of your participation in the study, including the screening and follow-up, will be around 12 weeks.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as closely monitoring your health and potentially improving your quality of life if empagliflozin proves effective for your FCF. However, there are also potential risks, including side effects from the medication, even if it's a dummy pill, though these are typically mild and temporary. The specific risks of empagliflozin will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • University Health Network
    Verified postcode
    Toronto, Canada

Common questions

What is Fontan Circulatory Failure (FCF)?

FCF happens when the single heart pumping chamber in people who've had the Fontan operation can't pump enough blood for the body's needs, making daily activities difficult.

What is empagliflozin?

Empagliflozin is a medication already used for other heart conditions and diabetes. This study wants to see if it can help people with FCF.

Will I know if I'm taking the real drug or a dummy pill?

No, neither you nor the doctors will know if you are taking empagliflozin or a dummy pill (placebo). This helps make the study results more reliable.

How long will I be in the study?

You'll be taking the study medication for 12 weeks, and your total participation, including checks before and after, will be around 12 weeks.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point without it affecting the care you receive from your doctors.

How to find out more

Official trial record

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 "SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Fa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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