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Efficacy and safety of low-dose digoxin in patients with heart failure. Rationale and design of the DECISION trial
Dirk J van Veldhuisen1, Michiel Rienstra1, Arend Mosterd2,3
1Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Insights
The DECISION trial investigated low-dose digoxin in heart failure (HF) patients. Results will clarify digoxin
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Digoxin, a long-standing cardiovascular drug, has shown mixed results in heart failure (HF) management.
- Previous trials may have used higher digoxin doses than optimal.
- Contemporary HF treatment guidelines have evolved, necessitating re-evaluation of digoxin's role.
Purpose of the Study:
- To evaluate the efficacy and safety of low-dose digoxin in patients with chronic HF and reduced or mildly reduced left ventricular ejection fraction (LVEF).
- To assess the impact of low-dose digoxin on cardiovascular mortality and HF hospitalizations within current HF treatment paradigms.
Main Methods:
- A randomized, double-blind, placebo-controlled trial (DECISION) involving 1002 patients with chronic HF and LVEF <50%.
- Patients were randomized (1:1) to receive low-dose digoxin or placebo, with dose adjustments to maintain target serum concentrations (0.5-0.9 ng/ml).
- The primary endpoint was a composite of cardiovascular mortality, HF hospitalizations, and urgent HF visits, with blind adjudication.
Main Results:
- Enrollment for the DECISION trial is complete with 1002 patients.
- The study is designed as an event-driven outcome trial with a median follow-up of 3 years.
- Final results are pending but expected to provide significant insights into low-dose digoxin's clinical utility.
Conclusions:
- The DECISION trial is poised to offer crucial evidence on the role of low-dose digoxin in contemporary heart failure management.
- Findings will inform clinical practice regarding the use of digoxin in patients with reduced or mildly reduced LVEF.
- The study addresses the long-standing question of digoxin's benefit in HF when administered at potentially safer, lower doses.
Aims:
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.
Methods:
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.
Conclusions:
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.
Clinical Trial Registration:
ClinicalTrials.gov identifier: NCT03783429.
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