Efficacy and safety of low-dose digoxin in patients with heart failure. Rationale and design of the DECISION trial.
Digoxin
Heart failure
Hospitalizations
Low‐dose
Mortality
Randomized clinical trial
Journal
European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595
Informations de publication
Date de publication:
30 Aug 2024
30 Aug 2024
Historique:
revised:
24
07
2024
received:
07
04
2024
accepted:
30
07
2024
medline:
31
8
2024
pubmed:
31
8
2024
entrez:
30
8
2024
Statut:
aheadofprint
Résumé
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. 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. 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. ClinicalTrials.gov identifier: NCT03783429.
Banques de données
ClinicalTrials.gov
['NCT03783429']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Dirk J van Veldhuisen
(DJ)
Peter van der Meer
(P)
Michiel Rienstra
(M)
Arend Mosterd
(A)
Marco Alings
(M)
Jan Tijssen
(J)
Thea van Asselt
(T)
Marcel Bouvy
(M)
Ernst E van der Wall
(EE)
Jeroen Schaap
(J)
Adriaan A Voors
(AA)
Harry J G M Crijns
(HJGM)
Carlo Gaillard
(C)
Nick Veeger
(N)
Informations de copyright
© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
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