Valvular & structural heart diseaseRandomised controlled trial
Digoxin in Patients With Symptomatic Rheumatic Heart Disease
- Randomised controlled trial
- multicentre
- placebo-controlled
- 1:1 randomisation stratified by baseline rhythm
Authors' conclusion
In patients with symptomatic rheumatic heart disease, digoxin reduced the risk of a composite of all-cause death or new-onset or worsening heart failure, with little risk of toxicity.
Study context
- Population
- Patients with symptomatic rheumatic heart disease plus HF or AF or already taking digoxin, 12 tertiary care hospitals in India, 2022–20241,759 in primary analysis
- Participants
- 1,769 patients
- Comparison
- Digoxin vs placebo
- Digoxinn = 885
- Placebon = 884reference
- Primary endpoint
- Composite of all-cause death or new-onset or worsening HF
- Follow-up
- Within 36 months or until study end
Primary result
As reported in the abstract
Hazard ratio
0.82
95% CI 0.70–0.97
P = 0.02
Events by treatment group
Digoxin vs Placebo
HR 0.82 (95% CI 0.70–0.97); P = 0.02
Secondary outcomes
| Outcome | Digoxin | Placebo | HR (95% CI) | |
|---|---|---|---|---|
| New-onset or worsening HF | 25.8% | 29.2% | 0.82 (0.69–0.98) | |
| All-cause death | 10% | 10.4% | 0.94 (0.70–1.26) | |
| 0.512Hazard ratio (log scale) |
- New-onset or worsening HF: most worsening HF episodes treated with oral or IV diuretic augmentation without hospitalisation
Safety
| Outcome | Digoxin | Placebo |
|---|---|---|
| Permanent discontinuation due to suspected digoxin toxicity | 1.1% | 1 events |
Original publication
Digoxin in Patients With Symptomatic Rheumatic Heart Disease. JAMA. Published 16 June 2026. doi:10.1001/jama.2026.7335
Summarised from the published abstract; every number is checked against it