TRED-HF2

• Research type

  Research Study

• Full title

  A randomised trial examining therapy to maintain remission in dilated cardiomyopathy

• IRAS ID

  1006543

• Contact name

  Brian Halliday

• Contact email

  b.halliday@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Eudract number

  2022-003734-39

• Research summary

  Dilated cardiomyopathy is a common disease of the heart muscle, where it becomes stretched and weak. After treatment with 4 medications, many patients experience resolution of symptoms and improvement in heart function. This is heart failure remission. Patients with heart failure remission often wish to reduce the number of medications they take to alleviate side effects and improve quality of life.
  In a previous trial, we showed that 2 out of 5 patients will experience a reduction in heart function if all medications are stopped. Our research suggested that one medication, beta-blockers, may be the most important to maintain remission. It is possible that some others are no longer required. Our research and focus groups conducted with patients and a patient charity have emphasised the importance of further studies investigating the feasibility of reducing the number of medications taken by patients with heart failure remission. This led to the design of this study.
  We will study 50 patients with remission of dilated cardiomyopathy who are taking 3-4 medications. Remission will be defined by 1) an improvement in left ventricular ejection fraction (a measure of heart function) to >50%, 2) an N-terminal propeptide of B-type natriuretic peptide (NT-pro-BNP; a blood test measuring heart stress) of <250ng/L and 3) resolution of heart failure symptoms. A computer will randomly select 25 patients to stop 1-2 medications (mineralocorticoid receptor antagonists and sodium glucose co-transporter 2 inhibitors) whilst continuing beta-blockers and medications that inhibit the renin-angiotensin system. The other 25 patients will continue all medications. We will perform heart MRI scans and blood tests and compare heart function between the groups over 4 months. Patients that continued therapy for the first half of the study will have the opportunity to stop the same 1-2 medications in the same fashion between 4-8 months.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  23/LO/0052

• Date of REC Opinion

  1 Aug 2023

• REC opinion

  Further Information Favourable Opinion