RECRUITINGINTERVENTIONAL

Therapy to Maintain Remission in Dilated Cardiomyopathy

A Randomised Trial Examining Therapy to Maintain Remission in Dilated Cardiomyopathy

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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). Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Other

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

Locations (1)

Royal Brompton Hospital

London, United Kingdom