TRED-HF

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Halliday BP, et al. "Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial". The Lancet. 2018. ePub 2018-11-09:1-13.
PubMedFull text

Clinical Question

In patients with dilated cardiomyopathy whose symptoms and cardiac function recover, does withdrawing medications increase the likelihood of relapsing dilated cardiomyopathy?

Bottom Line

Patients with dilated cardiomyopathy whose function recovers with treatment are at increased risk of relapse at 6 months if treatment is withdrawn.

Major Points

Guidelines

Design

  • Multicenter,open-label, pilot, randomized trial
  • N=51
    • Treatment withdrawal (n=25)
    • Continued treatment (n=26)
  • Setting: Recruitment from network of 7 UK hospitals, with assessment at a single center
  • Enrollment: 2016-2017
  • Mean follow-up: 6 months
  • Analysis: Intention-to-treat
  • Primary outcome: Relapse of dilated cardiomyopathy

Population

Inclusion Criteria

  • Previous diagnosis of dilated cardiomyopathy with LVEF ≤40%
  • Absence of current symptoms of heart failure
  • Current treatment with a loop diuretic, beta-blocker, angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or mineralocorticoid receptor antagonist
  • Current LVEF ≥50% and LVEDV indexed to body surface area within the normal range on cardiovascular magnetic resonance
  • Plasma NT-pro-BNP ≤250 ng/L

Exclusion Criteria

  • Uncontrolled hypertension defined by a clinic blood pressure >160/100 mmHg
  • Valvular disease of moderate or greater severity
  • eGFR <30 mL/min/1.73m2
  • Atrial, supraventricular, or ventricular arrhythmia requiring beta-blockade
  • Pregnancy
  • Angina
  • Age <16 years

Baseline Characteristics

  • Demographics: Age ## years, ##% female

Interventions

  • Randomized to:
    • Medication withdrawal: supervised, step-wise reduction in pharmacological treatment over a maximum of 16 weeks, with review every 2 weeks and subsequent medication changes
      • Clinic visit and NT-pro-BNP measurement every 4 weeks; interim review via phone if patient remained asymptomatic
    • Medication continuation: clinical review and NT-pro-BNP measurement after 8 weeks
  • At 16 weeks, all patients underwent clinical review and measurement of NT-pro-BNP concentration
  • At 6 months, patients underwent CMR scan to evaluate LV volume and functions, NT-pro-BNP measurement, and CPET, and completion of KCCQ and SAQ symptom questionnaires

Outcomes

Comparisons are GROUP NAME vs. GROUP NAME.

Primary Outcomes

PRIMARY OUTCOME NAME
Defined using CRITERIA 1, CRITERIA 2, CRITERIA 3...
##% vs. ##% (HR ##; 95% CI ##-##; P=0.##)

Secondary Outcomes

Subgroup Analysis

Adverse Events

Criticisms

Funding

Further Reading