- Question
- Does digoxin reduce mortality and hospitalization in patients with chronic heart failure and normal sinus rhythm?
- Design
- Randomized, double-blind, placebo-controlled trial. The main trial enrolled patients with a left ventricular ejection fraction of 0.45 or less (3397 on digoxin and 3403 on placebo), with an average follow-up of 37 months; an ancillary trial was also conducted in patients with an ejection fraction greater than 0.45 (492 on digoxin and 496 on placebo).
- Population
- Patients with chronic heart failure in normal sinus rhythm, with a left ventricular ejection fraction of 0.45 or less in the main trial, receiving diuretics and angiotensin-converting-enzyme inhibitors.
- Intervention
- Digoxin added to diuretics and ACE inhibitors, with a median dose of 0.25 mg per day.
- Control
- Placebo, in addition to diuretics and ACE inhibitors.
- Primary outcome
- All-cause mortality in the main trial; in the ancillary trial, the combined outcome of death or hospitalization due to worsening heart failure.
- Results
- Mortality was unaffected: 1181 deaths (34.8 percent) with digoxin versus 1194 (35.1 percent) with placebo (risk ratio 0.99; 95 percent confidence interval, 0.91 to 1.07; P=0.80). Fewer patients were hospitalized for worsening heart failure (26.8 percent vs. 34.7 percent; risk ratio 0.72; 95 percent confidence interval, 0.66 to 0.79; P<0.001).
- Conclusion
- Digoxin did not reduce overall mortality, but it reduced the rate of hospitalization both overall and for worsening heart failure.
- Why it matters
- The trial defined more precisely the role of digoxin as add-on therapy in chronic heart failure, showing a benefit on hospitalizations without an effect on survival.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 10, 2026