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Blinded withdrawal of randomized treatment with low-dose digoxin or placebo in heart failure: the DECISION trial

Peter van der Meer1, Dirk J van Veldhuisen1, Geert H D Voordes1

  • 1Department of Cardiology, University Medical Centre Groningen, University of Groningen, PO Box 30.001, Groningen 9700RB, The Netherlands.

European Heart Journal
|May 10, 2026
PubMed

Insights

Stopping digoxin in heart failure (HF) patients on optimal medical therapy is unsafe. Digoxin withdrawal significantly increased adverse events and clinical deterioration, highlighting the need for caution.

Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Medicine

Background:

  • The safety of discontinuing digoxin in heart failure (HF) patients receiving guideline-recommended therapy is not well-established.
  • This study analyzes data from the DECISION trial to assess outcomes after blinded digoxin withdrawal.

Purpose of the Study:

  • To evaluate the safety and clinical outcomes associated with digoxin withdrawal in patients with heart failure (HF) optimized on contemporary medical therapy.

Main Methods:

  • The DECISION trial randomized 1001 patients to digoxin or placebo.
  • A subset of 587 patients on active treatment underwent blinded withdrawal of digoxin or placebo, with follow-up at six weeks.
  • All cardiovascular events were adjudicated by an independent committee.

Main Results:

  • Digoxin withdrawal led to a significant increase in cardiovascular death or worsening heart failure events (42.8 vs. 5.9 events per 100 patient-years; P=0.036).
  • Patients withdrawing from digoxin experienced a 7.37-fold increased risk of adverse events compared to placebo withdrawal (P=0.012).
  • Digoxin withdrawal was associated with increased heart rate, decreased systolic blood pressure, and elevated NT-proBNP levels.

Conclusions:

  • Discontinuation of digoxin in patients with heart failure (HF) and reduced or mildly reduced ejection fraction, even after long-term treatment, is linked to clinical deterioration.
  • These findings underscore the importance of caution when considering stopping digoxin therapy in this patient population.
Abstract

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