RecruitingNot ApplicableNCT06091475

Therapy to Maintain Remission in Dilated Cardiomyopathy

A Randomised Trial Examining Therapy to Maintain Remission in Dilated Cardiomyopathy


Sponsor

Imperial College London

Enrollment

50 participants

Start Date

Dec 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. The TRED-HF trial investigated the impact of therapy withdrawal in this cohort and found that 40% of patients relapsed within 6 months of stopping treatment. In this follow-on study, the investigators will investigate the safety of therapy withdrawal of sodium cotransporter 2 inhibitors (SGLT2i) and mineralocorticord receptor anatagonists (MRAs) in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial to assess whether this maintains remission in this population.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with dilated cardiomyopathy — a condition where the heart muscle becomes weakened and enlarged — can safely reduce or stop their heart medications once their heart has recovered to normal function. **You may be eligible if...** - You have been diagnosed with dilated cardiomyopathy - Your heart function was once below 40% but has now recovered to above 50% - Your heart size is back to normal on imaging - Your heart failure blood marker (NT-pro-BNP) is low (below 250 ng/L) - You have no symptoms of heart failure (NYHA Class I) - You are in normal heart rhythm (sinus rhythm) - You are currently taking heart failure medications including a beta-blocker and either an ACE inhibitor, ARB, or sacubitril-valsartan, plus a water pill (MRA) or SGLT2 inhibitor **You may NOT be eligible if...** - You have atrial fibrillation (irregular heartbeat) - You have had dangerous heart rhythm problems (ventricular tachycardia or fibrillation) - You have certain genetic heart conditions (LMNA, DSP, FLNC, or RBM20 gene variants) - A close family member died suddenly of heart disease under age 50 - You have kidney disease (eGFR below 60) or are planning a pregnancy - You have active heart inflammation - You have diabetes managed with an SGLT2 inhibitor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOther

Withdrawal of mineralocorticoid receptor antagonists and/or sodium glucose cotransporter 2 inhibitors


Locations(1)

Royal Brompton Hospital

London, United Kingdom

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NCT06091475


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