Therapy to Maintain Remission in Dilated Cardiomyopathy
Recruiting · NCT06091475 · Interventional (participants receive a specific treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Royal Brompton Hospital - London, United Kingdom