TY - JOUR
T1 - Heart failure patients with reduced or mildly reduced ejection fraction
T2 - baseline characteristics of the low-dose digoxin outcome DECISION trial
AU - DECISION Investigators
AU - van der Meer, Peter
AU - Voordes, Geert H D
AU - Vijver, Marlene A T
AU - Mosterd, Arend
AU - Alings, A Marco
AU - Maas-Soer, Ester L
AU - de Vos, Agaath H
AU - Schut, Astrid
AU - van Asselt, Antoinette D
AU - Bouvy, Marcel L
AU - Tijssen, Jan G P
AU - Damman, Kevin
AU - Schaap, Jeroen
AU - van der Wall, Ernst E
AU - Voors, Adriaan A
AU - Crijns, Harry J
AU - Lok, Dirk J
AU - Westendorp, Iris C
AU - Rienstra, Michiel
AU - van Veldhuisen, Dirk J
N1 - © The Author(s) 2026. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact [email protected] for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact [email protected].
PY - 2026/3/13
Y1 - 2026/3/13
N2 - AIMS: This report describes the baseline characteristics of the DECISION trial (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) and compares these with the other trials of cardiac glycosides in heart failure (HF): DIG and DIGIT-HF.METHODS: The DECISION trial is a randomized, double-blind, parallel-group, placebo-controlled outcome trial investigating of low-dose digoxin in contemporary patients with heart failure with a left ventricular ejection fraction (LVEF) ≤50%. Patients were randomized 1:1 to low-dose digoxin or placebo. During follow-up, serum digoxin concentrations were monitored to achieve concentrations of 0.5-0.9 ng/ml. The primary endpoint is a composite of cardiovascular mortality, total HF-hospitalizations and urgent HF hospital visits.RESULTS: A total of 1002 patients were randomized to digoxin or placebo and 1001 patients were included in the full analysis set. Mean age was 73 ± 9 years, 28% were women and 88% were in New York Heart Association class II. Mean LVEF was 33 ± 9%, and 79% had a LVEF ≤40%. At baseline, 71% had sinus rhythm and 29% had atrial fibrillation. Median N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 1404 pg/ml [930-2359].Patients were well-treated with guideline-directed medical therapy (GDMT): beta-blockers (86%), ACE inhibitors or ARBs or angiotensin receptor-neprilysin inhibitors (89%), mineralocorticoid receptor antagonists (72%), and sodium-glucose co-transporter 2 inhibitors (41%) and loop-diuretics (74%). Compare to other digitalis trials, DECISION-patients were older, more often women and had high prevalence of GDMT.CONCLUSION: DECISION enrolled a contemporary and well-treated population of patients with HFrEF and HFmrEF and will provide important evidence regarding the efficacy and safety of low-dose digoxin on outcome in patients with reduced or mildly reduced LVEF.
AB - AIMS: This report describes the baseline characteristics of the DECISION trial (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) and compares these with the other trials of cardiac glycosides in heart failure (HF): DIG and DIGIT-HF.METHODS: The DECISION trial is a randomized, double-blind, parallel-group, placebo-controlled outcome trial investigating of low-dose digoxin in contemporary patients with heart failure with a left ventricular ejection fraction (LVEF) ≤50%. Patients were randomized 1:1 to low-dose digoxin or placebo. During follow-up, serum digoxin concentrations were monitored to achieve concentrations of 0.5-0.9 ng/ml. The primary endpoint is a composite of cardiovascular mortality, total HF-hospitalizations and urgent HF hospital visits.RESULTS: A total of 1002 patients were randomized to digoxin or placebo and 1001 patients were included in the full analysis set. Mean age was 73 ± 9 years, 28% were women and 88% were in New York Heart Association class II. Mean LVEF was 33 ± 9%, and 79% had a LVEF ≤40%. At baseline, 71% had sinus rhythm and 29% had atrial fibrillation. Median N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 1404 pg/ml [930-2359].Patients were well-treated with guideline-directed medical therapy (GDMT): beta-blockers (86%), ACE inhibitors or ARBs or angiotensin receptor-neprilysin inhibitors (89%), mineralocorticoid receptor antagonists (72%), and sodium-glucose co-transporter 2 inhibitors (41%) and loop-diuretics (74%). Compare to other digitalis trials, DECISION-patients were older, more often women and had high prevalence of GDMT.CONCLUSION: DECISION enrolled a contemporary and well-treated population of patients with HFrEF and HFmrEF and will provide important evidence regarding the efficacy and safety of low-dose digoxin on outcome in patients with reduced or mildly reduced LVEF.
U2 - 10.1093/ejhf/xuag073
DO - 10.1093/ejhf/xuag073
M3 - Article
C2 - 41823368
SN - 1388-9842
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
M1 - xuag073
ER -