Therapy to Maintain Remission in Dilated Cardiomyopathy

Recruiting now · Not applicable

Conditions studied: Heart Failure, Cardiomyopathy, Dilated, Cardiomyopathies, Heart Diseases

In brief

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.

Key facts

Study ID

NCT06091475

Run by

Imperial College London

People needed

50

Starts

2023-12-02

Expected to finish

2026-09-15

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• a diagnosis of dilated cardiomyopathy,
• previous left ventricular ejection fraction (LVEF) <40% (on echocardiography or cardiovascular magnetic resonance [CMR]),
• current LVEF >50% with normal left ventricular end-diastolic volume (LVEDV),
• plasma NT-pro-BNP<250ng/L,
• New York Heart Association (NYHA) class I,
• sinus rhythm,
• taking a beta-blocker and an angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or sacubitril-valsartan, along with either a mineralocorticoid receptor antagonist (MRA) and/or sodium glucose co-transporter 2 inhibitor (SGLT2i).

You may not qualify if…

• Atrial fibrillation,
• prior sustained ventricular tachycardia or fibrillation,
• a known likely pathogenic or pathogenic variant in LMNA/DSP/FLNC/RBM20,
• sudden cardiac or heart failure death in a first degree relative <50 years,
• contraindication to CMR,
• estimated glomerular filtration rate (eGFR) <60mls/min,
• planned pregnancy,8) active myocardial inflammation,
• diabetes mellitus managed with an SGLT2i, 10) urinary albumin-to-creatine ratio of 200-5000 (mg:g) and eGFR< 75mls/min.

Where it is running

• Royal Brompton Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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