Therapy to Maintain Remission in Dilated Cardiomyopathy

• Status: Not yet recruiting
• Trial end date: 2026-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: Royal Brompton & Harefield NHS Foundation Trust
• Treatments: Dapagliflozin; Empagliflozin; Eplerenone; Spironolactone

Criteria

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.