Efficacy and safety of low-dose digoxin in patients with heart failure. Rationale and design of the DECISION trial

DECISION Investigators and Committees, Dirk J van Veldhuisen*, Michiel Rienstra, Arend Mosterd, A Marco Alings, Antoinette D J van Asselt, Marcel L Bouvy, Jan G P Tijssen, Jeroen Schaap, Ernst E van der Wall, Adriaan A Voors, Eva M Boorsma, Dirk J A Lok, Harry J G M Crijns, Astrid Schut, Marlene A T Vijver, Geert H D Voordes, Agaath H de Vos, Ester L Maas-Soer, Nicoline W SmitDaan J Touw, Michelle Samuel, Peter van der Meer

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Aims: Digoxin is the oldest drug in cardiovascular (CV) medicine, and one trial conducted >25 years ago showed a reduction in heart failure (HF) hospitalizations but no effect on mortality. However, later studies suggested that the dose of digoxin used in that trial (and other studies) may have been too high. The DECISION (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) trial will examine the efficacy and safety of low-dose digoxin in HF patients with reduced or mildly reduced left ventricular ejection fraction (LVEF) with a background of contemporary HF treatment. Methods: The DECISION trial is a randomized, double-blind, parallel-group, placebo-controlled event-driven outcome trial which will investigate the efficacy and safety of low-dose digoxin in patients with chronic HF and LVEF <50%. Both patients with sinus rhythm and atrial fibrillation will be enrolled and will be randomized (1:1) to low-dose digoxin or matching placebo. To maintain a target serum digoxin concentration of 0.5–0.9 ng/ml, dose adjustments are made throughout follow-up based on serum digoxin measurements with dummy values for the placebo group. The primary endpoint is a composite of CV mortality and total HF hospitalizations or total urgent hospital visits for worsening HF, and all endpoints are adjudicated blindly by a Clinical Event Committee. The estimated sample size was 982 patients who will be followed for a median of 3 years, and in December 2023 enrolment was completed after 1002 patients. Conclusions: The DECISION trial will provide important evidence regarding the effect of (low-dose) digoxin on CV mortality and total HF hospitalizations and urgent hospital visits when added to contemporary HF treatment of patients with reduced or mildly reduced LVEF. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03783429.

Original languageEnglish
Pages (from-to)2223-2230
Number of pages8
JournalEuropean Journal of Heart Failure
Volume26
Issue number10
Early online date30 Aug 2024
DOIs
Publication statusPublished - Oct 2024

Bibliographical note

© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Funding

DECISION is an investigator\u2010initiated trial conducted and led by the principal investigators from the University Medical Center Groningen who are responsible for all aspects of the study protocol. Members of the steering committee advise on the study protocol and ensure scientific quality of the trial. The DECISION trial is supported by the Netherlands Research Organization and funded by the Netherlands Heart Foundation (grant 2018B024). The DECISION trial is financially supported by the Netherlands Heart Foundation (grant 2018B024). Additional funding is obtained from the Cardiology Fund of the UMC Groningen.

FundersFunder number
Netherlands Research Organization
Hartstichting2018B024

    Keywords

    • Digoxin
    • Heart failure
    • Hospitalizations
    • Low-dose
    • Mortality
    • Randomized clinical trial

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