TRED-HF - TRED-HF

Nov 11, 2018
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
British Heart Foundation, Alexander Jansons Foundation, Royal Brompton Hospital and Imperial College London, Imperial College Biomedical Research Centre, Wellcome Trust, and Rosetrees Trust.
Date Presented:
11/11/2018
Date Published:
11/11/2018
Date Updated:
11/11/2018
Original Posted Date:
11/11/2018
References

Contribution To Literature:

The TRED-HF trial showed that withdrawal of HF medications among patients with DCM who had recovered their LV function results in relapse of HF.

Description:

The goal of the trial was to assess the safety and efficacy of withdrawal of heart failure (HF) medications among patients with dilated cardiomyopathy (DCM) who had recovered their left ventricular ejection fraction (LVEF).


Study Design

Eligible patients were randomized in a 1:1 fashion to either withdrawal of HF medications (n = 25) or continuation of medications (n = 26). After 6 months, patients in the medication continuation arm crossed over to medication discontinuation.

  • Total number of enrollees: 51
  • Duration of follow-up: 6 months
  • Mean patient age: 55 years
  • Percentage female: 33%

Inclusion criteria:

Prior diagnosis of DCM:

  • Dilated and LVEF <40% at diagnosis

Subsequent recovery:

  • LVEF >50%
  • Normal LV end-diastolic volume index
  • N-terminal pro–B-type natriuretic peptide <250 ng/L
  • New York Heart Association class I

Exclusion criteria:

  • Arrhythmia requiring beta-blocker
  • Uncontrolled hypertension
  • Valvular disease (moderate or greater)
  • Estimated glomerular filtration rate <30 ml/min
  • Pregnancy
  • Angina
  • Age <16 years

Other salient features/characteristics:

  • Time since DCM diagnosis: 27 months
  • Absolute improvement in LVEF: 30%
  • Time since LVEF >50%: 25 months
  • Medications: angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers: 100%, beta-blockers: 88%, mineralocorticoid receptor antagonists: 47%

Principal Findings:

The primary outcome, relapse of HF, for drug discontinuation vs. continuation, was 44% vs. 0%, p = 0.0001. In the control (continuation) arm, following 6-month cross-over, relapse occurred in 36% of patients.

All patients with relapse were asymptomatic, and 85% of relapsed patients still had an LVEF >50%.

Secondary outcomes, for drug discontinuation vs. continuation:

  • Death: 0% vs. 0%
  • Atrial fibrillation: 3 vs. 0 patients

Interpretation:

The results of this trial indicate that withdrawal of HF medications among patients with DCM who had recovered their LV function results in relapse of HF, and should probably be avoided unless necessary and until predictors of relapse can be better outlined. Relapse was asymptomatic in all patients over the duration of follow-up – it is possible that they would have gone on to develop HF symptoms with longer follow-up. Limitations include small sample size, unblinded design, and single-center study.

References:

Halliday BP, Wassall R, Lota AS, et al. Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial. Lancet 2018;Nov 11:[Epub ahead of print].

Editorial Comment: Wilcox J, Yancy CW. Stopping medication for heart failure with improved ejection fraction. Lancet 2018;Nov 11:[Epub ahead of print].

Presented by Dr. Brian P. Halliday at the American Heart Association Annual Scientific Sessions (AHA 2018), Chicago, IL, November 11, 2018.

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: AHA Annual Scientific Sessions, AHA18, Adrenergic beta-Antagonists, Angiotensin-Converting Enzyme Inhibitors, Angiotensin Receptor Antagonists, Atrial Fibrillation, Cardiomyopathy, Dilated, Heart Failure, Medication Adherence, Natriuretic Peptide, Brain, Primary Prevention, Stroke Volume, Ventricular Function, Left


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