European journal of heart failure · 2026
Heart failure patients with reduced or mildly reduced ejection fraction: baseline characteristics of the low-dose digoxin outcome DECISION trial.
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van der Meer Peter, Voordes Geert H D, Vijver Marlene A T, Mosterd Arend, Alings A Marco, Maas-Soer Ester L, de Vos Agaath H, Schut Astrid, van Asselt Antoinette D, Bouvy Marcel L, Tijssen Jan G P, Damman Kevin, Schaap Jeroen, van der Wall Ernst E, Voors Adriaan A, Crijns Harry J, Lok Dirk J, Westendorp Iris C, Rienstra Michiel, van Veldhuisen Dirk J, DECISION Investigators
Аннотация
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.
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.