Heart failure & cardiomyopathiesRandomised controlled trial
Digitoxin in Patients with Heart Failure and Reduced Ejection Fraction
- Randomised controlled trial
- international
- double-blind
- placebo-controlled
Authors' conclusion
Treatment with digitoxin led to a lower combined risk of death from any cause or hospital admission for worsening heart failure than placebo among patients with heart failure and reduced ejection fraction who received guideline-directed medical therapy.
Study context
- Population
- Chronic HF with LVEF ≤40% and New York Heart Association (NYHA) III–IV, or LVEF ≤30% and NYHA II, on guideline-directed medical therapy1,212 in modified ITT population
- Participants
- 1,240 participants
- Comparison
- Digitoxin vs placebo, added to guideline-directed medical therapy
- Digitoxinn = 613
- Placebon = 599reference
- Primary endpoint
- Composite of:
- All-cause death
- Hospital admission for worsening HF
- Follow-up
- Median 36 months
Primary result
As reported in the abstract
Hazard ratio
0.82
95% CI 0.69–0.98
P = 0.03
Events by treatment group
Digitoxin vs Placebo
HR 0.82 (95% CI 0.69–0.98); P = 0.03
Further findings
| Outcome | Digitoxin | Placebo | HR (95% CI) | |
|---|---|---|---|---|
| All-cause death | 27.2% | 29.5% | 0.86 (0.69–1.07) | |
| First hospital admission for worsening HF | 28.1% | 30.4% | 0.85 (0.69–1.05) | |
| 0.512Hazard ratio (log scale) |
Safety
At least one serious adverse event
Original publication
Digitoxin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. Published 29 August 2025. doi:10.1056/nejmoa2415471
Summarised from the published abstract; every number is checked against it