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Heart failure patients with reduced or mildly reduced ejection fraction: baseline characteristics of the low-dose
Peter van der Meer1, Geert H D Voordes1, Marlene A T Vijver1
1University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.
Insights
The DECISION trial evaluated low-dose digoxin in heart failure patients, comparing it to placebo. This study provides crucial data on digoxin
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Heart failure (HF) remains a significant global health challenge.
- Cardiac glycosides, like digoxin, have been used for decades in HF management.
- Contemporary HF populations differ from those in previous digitalis trials.
Purpose of the Study:
- To describe baseline characteristics of the DECISION trial.
- To compare DECISION trial participants with those in prior cardiac glycoside HF studies (DIG, DIGIT-HF).
- To investigate the efficacy and safety of low-dose digoxin in patients with reduced or mildly reduced left ventricular ejection fraction (LVEF).
Main Methods:
- The DECISION trial is a randomized, double-blind, placebo-controlled outcome study.
- 1002 patients with LVEF ≤50% were randomized 1:1 to low-dose digoxin or placebo.
- Serum digoxin concentrations were monitored (target 0.5-0.9 ng/ml); primary endpoint included cardiovascular mortality and HF hospitalizations.
Main Results:
- DECISION enrolled 1002 patients (mean age 73 years, 28% women, 88% NYHA class II).
- Mean LVEF was 33±9%, with 79% having LVEF ≤40%.
- Patients were well-treated with guideline-directed medical therapy (GDMT), including beta-blockers (86%), ACEi/ARBs/ARNis (89%), MRAs (72%), and SGLT2i (41%).
Conclusions:
- The DECISION trial enrolled a contemporary, well-treated cohort of patients with HFrEF and HFmrEF.
- This study will offer vital evidence on the efficacy and safety of low-dose digoxin in this population.
- Findings will inform clinical practice regarding digoxin use in modern heart failure management.
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.
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