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Therapy to Maintain Remission in Dilated Cardiomyopathy

RECRUITINGN/ASponsored by Imperial College London
Actively Recruiting
PhaseN/A
SponsorImperial College London
Started2023-12-02
Est. completion2026-08-15
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted

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

Age: 18 Years – 85 YearsHealthy volunteers accepted
Inclusion Criteria:

1. a diagnosis of dilated cardiomyopathy,
2. previous left ventricular ejection fraction (LVEF) \<40% (on echocardiography or cardiovascular magnetic resonance \[CMR\]),
3. current LVEF \>50% with normal left ventricular end-diastolic volume (LVEDV),
4. plasma NT-pro-BNP\<250ng/L,
5. New York Heart Association (NYHA) class I,
6. sinus rhythm,
7. 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).

Exclusion Criteria:

1. Atrial fibrillation,
2. prior sustained ventricular tachycardia or fibrillation,
3. a known likely pathogenic or pathogenic variant in LMNA/DSP/FLNC/RBM20,
4. sudden cardiac or heart failure death in a first degree relative \<50 years,
5. contraindication to CMR,
6. estimated glomerular filtration rate (eGFR) \<60mls/min,
7. planned pregnancy,8) active myocardial inflammation,

9\) diabetes mellitus managed with an SGLT2i, 10) urinary albumin-to-creatine ratio of 200-5000 (mg:g) and eGFR\< 75mls/min.

Conditions5

CardiomyopathiesCardiomyopathy, DilatedHeart DiseaseHeart DiseasesHeart Failure

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