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

Autor: van Veldhuisen DJ; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Rienstra M; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Mosterd A; Department of Cardiology, Meander Medisch Centrum, Amersfoort, The Netherlands.; Workgroup Cardiology Centers, Utrecht, The Netherlands., Alings AM; Workgroup Cardiology Centers, Utrecht, The Netherlands.; Department of Cardiology, Amphia Medical Center, Breda, The Netherlands., van Asselt ADJ; Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Bouvy ML; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands., Tijssen JGP; Department of Cardiology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands., Schaap J; Workgroup Cardiology Centers, Utrecht, The Netherlands.; Department of Cardiology, Amphia Medical Center, Breda, The Netherlands., van der Wall EE; Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands., Voors AA; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Boorsma EM; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Lok DJA; Department of Cardiology, Deventer Hospital, Deventer, The Netherlands., Crijns HJGM; Department of Cardiology and Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, The Netherlands., Schut A; Workgroup Cardiology Centers, Utrecht, The Netherlands., Vijver MAT; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Voordes GHD; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., de Vos AH; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Maas-Soer EL; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Smit NW; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Touw DJ; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., Samuel M; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands., van der Meer P; Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2024 Oct; Vol. 26 (10), pp. 2223-2230. Date of Electronic Publication: 2024 Aug 30.
DOI: 10.1002/ejhf.3428
Abstrakt: 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.
(© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
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