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Status:

RECRUITING

Therapy to Maintain Remission in Dilated Cardiomyopathy

Lead Sponsor:

Imperial College London

Collaborating Sponsors:

Royal Brompton & Harefield NHS Foundation Trust

Conditions:

Heart Failure

Cardiomyopathy, Dilated

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

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 investigat...

Detailed Description

One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. These patients have an excel...

Eligibility Criteria

Inclusion

  • 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

  • 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,
  • 9\) diabetes mellitus managed with an SGLT2i, 10) urinary albumin-to-creatine ratio of 200-5000 (mg:g) and eGFR\< 75mls/min.

Key Trial Info

Start Date :

December 2 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 15 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06091475

Start Date

December 2 2023

End Date

September 15 2026

Last Update

September 19 2024

Active Locations (1)

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1

Royal Brompton Hospital

London, United Kingdom