RecruitingNAINTERVENTIONAL

Therapy to Maintain Remission in Dilated Cardiomyopathy

This study is for people who have had heart failure due to a condition called dilated cardiomyopathy but have since recovered, meaning their heart is now working much better. We know that some people who stop all their heart medication after recovery can experience their heart problems returning. This new study aims to find out if it's safe for people in this situation to carefully stop taking two specific types of heart failure medicines — SGLT2 inhibitors and MRAs — while staying on others. The goal is to see if this approach can help maintain their improved heart health.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

02 Dec 2023

Estimated completion

15 Sep 2026

Heart Failure Cardiomyopathy, Dilated Cardiomyopathies Heart Diseases

What is this study about?

When someone is diagnosed with heart failure, it means their heart isn't pumping blood around their body as well as it should. For about one in three people with a specific type called dilated cardiomyopathy, their heart can actually get much better after a period of treatment with medicines. This is great news, and it means their heart's pumping ability has largely recovered. However, doctors aren't entirely sure if these people need to stay on all their heart medicines for the long term.

A previous study called TRED-HF showed that if people who had recovered from heart failure completely stopped all their heart medicines, about 40% of them found their heart problems came back within six months. This suggests that while their heart is much better, they might still benefit from some ongoing treatment. This new study is a follow-up to TRED-HF. It will look more closely at whether carefully reducing certain heart medications—specifically SGLT2 inhibitors and MRAs—while staying on other key medications like beta-blockers and ACE inhibitors, can help people maintain their improved heart health without their condition worsening.

The aim is to understand what medicine combination is best for people whose hearts have recovered from diligent cardiomyopathy, ensuring they stay well while avoiding unnecessary medications. This research is important because it could help doctors provide clearer advice to many people living with this condition.

Key takeaways

This study explores safely reducing heart medication in recovered heart failure.
It focuses on people with dilated cardiomyopathy whose heart function has improved.
Researchers will look at stopping SGLT2 inhibitors and MRAs one by one.
Close monitoring with heart scans and blood tests will happen for 8 months.
The goal is to understand how to best maintain heart health in the long term.

Who may be eligible?

This study is looking for adults aged 18 to 85 who have been diagnosed with dilated cardiomyopathy and whose heart function has since largely recovered. This means your heart was previously weak but is now pumping blood strongly, and your doctor has told you your heart's size and function are nearly normal. You should also be feeling well and have a normal heart rhythm. To be considered, you must currently be taking a beta-blocker, an ACE inhibitor (or a similar medicine like ARB or sacubitril-valsartan), and also either an MRA or an SGLT2 inhibitor, or both.

There are several reasons why you might not be able to join the study. For example, if you have an irregular heartbeat (atrial fibrillation), or if you've had certain serious heart rhythm problems in the past. If you or a close family member had an unexplained sudden heart problem before age 50, that would also exclude you. We also can't include you if you have certain genetic conditions affecting the heart, or if you can't have an MRI scan. Your kidney function needs to be good, and if you have diabetes and are taking an SGLT2 inhibitor for it, you wouldn't be able to participate.

Quick self-check

Do you have a diagnosis of dilated cardiomyopathy?
Has your heart function largely recovered (it's pumping much better now)?
Are you aged between 18 and 85?
Are you currently taking a beta-blocker, an ACE inhibitor (or similar), AND an MRA and/or SGLT2 inhibitor?
Do you have a regular heartbeat (not atrial fibrillation)?
Have you *not* had certain serious heart rhythm problems or a close family member with sudden heart death under 50?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, your involvement would last for eight months. You would continue taking your usual heart medications (a beta-blocker and an ACE inhibitor/ARB). The study would involve carefully and gradually stopping either your MRA or SGLT2 inhibitor, and then the other, one at a time. Throughout the study, you would have regular appointments to check your heart health. This would include special heart scans called cardiovascular magnetic resonance (CMR) scans, as well as blood tests. These checks will help the doctors see how your heart is responding to the changes in medication and ensure you remain well.

Potential risks and benefits

Participating in this study might help us understand the best way to manage heart failure in people who have recovered, potentially leading to clearer guidance for everyone in the future. For you personally, the main benefit is contributing to important medical knowledge. However, there's a risk that reducing your medication could lead to your heart problems returning or worsening, which we would monitor very closely. We would quickly restart any necessary medication if this happened. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Royal Brompton Hospital
London, United Kingdom· Recruiting

Common questions

What is dilated cardiomyopathy?

It's a condition where the heart muscle becomes stretched and thin, making it harder for the heart to pump blood effectively.

What does 'remission' mean for heart failure?

It means your heart's pumping ability has significantly improved, and your symptoms are very mild or gone, but the original problem might still be there.

What are SGLT2i and MRA medications?

These are two types of medicines commonly used in heart failure treatment. SGLT2i help the kidneys remove sugar and salt, benefiting the heart. MRAs protect the heart from certain hormones.

Will I have to stop all my heart medication?

No, you will remain on your beta-blocker and ACE inhibitor (or similar) throughout the study. Only your SGLT2 inhibitor and MRA would be considered for withdrawal, one at a time.

What happens if my heart condition gets worse during the study?

The study team will be monitoring you very closely. If there are any signs your heart condition is worsening, they will quickly restart your medication to ensure your safety and well-being.

How to find out more

Saad Javed, MBChB

tred2trial@imperial.ac.uk 02073528121 Official trial record

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