Heart Failure Clinical Trial
— TRED-HF2Official title:
A Randomised Trial Examining Therapy to Maintain Remission in Dilated Cardiomyopathy
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 15, 2026 |
Est. primary completion date | August 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Imperial College London | Royal Brompton & Harefield NHS Foundation Trust |
Halliday BP, Wassall R, Lota AS, Khalique Z, Gregson J, Newsome S, Jackson R, Rahneva T, Wage R, Smith G, Venneri L, Tayal U, Auger D, Midwinter W, Whiffin N, Rajani R, Dungu JN, Pantazis A, Cook SA, Ware JS, Baksi AJ, Pennell DJ, Rosen SD, Cowie MR, Cleland JGF, Prasad SK. Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial. Lancet. 2019 Jan 5;393(10166):61-73. doi: 10.1016/S0140-6736(18)32484-X. Epub 2018 Nov 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart Failure Relapse assessed through left ventricular ejection fraction (LVEF) | Relapse of DCM defined by a reduction in LVEF>10% and to below 50% | 32 weeks | |
Primary | Heart Failure Relapse assessed through pro-BNP | Relapse of DCM defined by a two-fold rise in NT-pro-BNP and to >400ng/L | 32 weeks | |
Primary | Number of patients with heart failure Relapse assessed through signs of heart failure | Relapse of DCM defined by clinical signs of heart failure as determined by the research team | 32 weeks | |
Primary | Number of patients with heart failure Relapse assessed through symptoms of heart failure | Relapse of DCM defined by clinical symptoms of heart failure as determined by the research team | 32 weeks | |
Secondary | Left ventricular ejection fraction (LVEF) | Change in LVEF between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks) | 32 weeks | |
Secondary | Left Ventricular End-Diastolic Volume Index indexed to body surface area (ml/m2) (LVEDVi) | Change in LVEDVi between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks) | 32 weeks | |
Secondary | left ventricular global longitudinal strain (LV GLS) | Change in LV GLS between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks) | 32 weeks | |
Secondary | left ventricular mass index (LVMi; g/m2) | Change in LVMI between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks) | 32 weeks | |
Secondary | left atrial volume index (LAVi; ml/m2) | Change in LAVi between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks) | 32 weeks | |
Secondary | left atrial strain (LAS) | Change in LAS between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks) | 32 weeks | |
Secondary | right ventricular ejection fraction (RVEF; %) | Change in RVEF between baseline, during randomised phase (0-16 weeks) and follow-on phase (16-32 weeks) | 32 weeks | |
Secondary | Change in Quality of Life (EQ-5D-5L score) | Assessed through EQ-5D-5L score. This is a validated score from the EuroQoL research foundation, graded from 5 to 25 with a higher score reflecting a worse quality of life | 32 weeks | |
Secondary | Change in Quality of Life (Treatment Burden Questionnaire score) | Assessed through TBQ (Treatment Burden Questionnaire) score. The TBQ score is graded from 0 to 150 with a higher score reflecting a greater treatment burden | 32 weeks |
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