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Search / Trial NCT06091475

Therapy to Maintain Remission in Dilated Cardiomyopathy

Launched by IMPERIAL COLLEGE LONDON · Oct 17, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cardiomyopathy Heart Failure

ClinConnect Summary

The TRED-HF trial is studying how stopping certain heart medications affects patients who have previously improved from heart failure caused by dilated cardiomyopathy. In earlier research, they found that about 40% of patients experienced a return of their heart issues within six months after their treatment was stopped. This new study aims to see if withdrawing medications like SGLT2 inhibitors and mineralocorticoid receptor antagonists is safe and helps maintain recovery in patients who are currently doing well.

To be eligible for this trial, participants should have a history of dilated cardiomyopathy, previous heart function below 40%, and current heart function above 50%. They should also be stable and on specific heart medications. This study is open to all adults aged 65 to 74 years, and participants can expect to be closely monitored for their heart health and any changes during the trial. It’s important to note that certain conditions, such as a history of irregular heartbeats or specific genetic factors, may exclude someone from joining.

Gender

ALL

Eligibility 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.

About Imperial College London

Imperial College London is a world-renowned research institution based in the United Kingdom, recognized for its commitment to advancing medical science and improving patient care through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, Imperial combines expertise across various fields, including medicine, engineering, and business, to drive breakthroughs in healthcare. The institution’s robust clinical trial programs are designed to evaluate new therapies and interventions, ensuring rigorous scientific standards and ethical practices while aiming to translate research findings into tangible benefits for patients and society.

Locations

London, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Brian P Halliday, MBChB

Principal Investigator

Imperial College London, Royal Brompton Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported