Therapy to Maintain Remission in Dilated Cardiomyopathy
NCT06091475
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
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
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT06091475