Therapy to Maintain Heart Function in Patients with Dilated Cardiomyopathy
A Randomised Trial Examining Therapy to Maintain Remission in Dilated Cardiomyopathy
This study is testing whether stopping certain heart medications is safe for people with dilated cardiomyopathy who have improved heart function, to see how to best manage their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06091475 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and feasibility of withdrawing certain heart medications in patients with dilated cardiomyopathy who have shown recovery of cardiac function. Following the TRED-HF trial, which found that many patients relapse after stopping treatment, this trial aims to determine the necessary therapies to maintain remission in these patients. Participants will be randomly assigned to either continue or withdraw from treatment with sodium cotransporter 2 inhibitors and mineralocorticoid receptor antagonists. The goal is to identify optimal management strategies for patients who have improved cardiac function.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with dilated cardiomyopathy who have previously experienced heart failure but currently have recovered cardiac function.
Not a fit: Patients with ongoing heart failure symptoms or those with specific genetic markers related to cardiomyopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the minimum necessary treatment for patients with dilated cardiomyopathy, potentially reducing medication burden while maintaining heart function.
How similar studies have performed: Previous studies, such as the TRED-HF trial, have shown that therapy withdrawal can lead to relapse in a significant portion of patients, indicating the need for further investigation in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Brian P Halliday, MBChB — Imperial College London, Royal Brompton Hospital
- Study coordinator: Saad Javed, MBChB
- Email: tred2trial@imperial.ac.uk
- Phone: 02073528121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.