Therapy to Maintain Remission in Dilated Cardiomyopathy
A Randomised Trial Examining Therapy to Maintain Remission in Dilated Cardiomyopathy
Imperial College London
50 participants
Dec 2, 2023
INTERVENTIONAL
Conditions
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 Criteria7
- 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).
Exclusion Criteria8
- 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.
Interventions
Withdrawal of mineralocorticoid receptor antagonists and/or sodium glucose cotransporter 2 inhibitors
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06091475