Heart failure patients with reduced or mildly reduced ejection fraction: baseline characteristics of the low-dose digoxin outcome DECISION trial.

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.