Actively Recruiting
Therapy to Maintain Remission in Dilated Cardiomyopathy
Led by Imperial College London · Updated on 2024-09-19
50
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
R
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Therapy to Maintain Remission in Dilated Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of dilated cardiomyopathy
- Previous left ventricular ejection fraction (LVEF) below 40% measured by echocardiography or cardiovascular magnetic resonance (CMR)
- Current LVEF above 50% with normal left ventricular end-diastolic volume (LVEDV)
- Plasma NT-pro-BNP level below 250 ng/L
- New York Heart Association (NYHA) class I
- Sinus rhythm
- Taking beta-blocker and angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), or sacubitril-valsartan, plus either mineralocorticoid receptor antagonist (MRA) and/or sodium glucose co-transporter 2 inhibitor (SGLT2i)
You will not qualify if you...
- Atrial fibrillation
- Prior sustained ventricular tachycardia or fibrillation
- Known likely pathogenic or pathogenic genetic variant in LMNA, DSP, FLNC, or RBM20
- Sudden cardiac or heart failure death in a first-degree relative younger than 50 years
- Contraindication to cardiovascular magnetic resonance (CMR) imaging
- Estimated glomerular filtration rate (eGFR) below 60 ml/min
- Planned pregnancy
- Active myocardial inflammation
- Diabetes mellitus treated with an SGLT2 inhibitor
- Urinary albumin-to-creatinine ratio of 200-5000 mg/g and eGFR below 75 ml/min
AI-Screening
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Trial Site Locations
Total: 1 location
1
Royal Brompton Hospital
London, United Kingdom
Actively Recruiting
Research Team
S
Saad Javed, MBChB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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