Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial
Primary resultResult — go to the resultHazard ratio 0.92 95% CI 0.78–1.09- stopped early for futility after planned interim analysis
Authors' conclusion
Among patients receiving maintenance dialysis, spironolactone 25 mg daily orally did not reduce the composite outcome of cardiovascular mortality and hospitalisation due to heart failure compared with placebo.
Study context
- Population
- Patients on maintenance dialysis for kidney failure ≥3 months, aged ≥45 years or ≥18 years with diabetes; 143 dialysis programmes in 12 countriesmedian follow-up 1.8 years
- Participants
- 2,538 patients
- Comparison
- Spironolactone vs placebo
- Spironolactonen = 1,260
- Placebon = 1,278reference
- Primary endpoint
- Composite of:
- CV mortality
- Hospitalisation for HF (time-to-event)
Methodological detailsinternational, parallel-group, double-blind, placebo-controlled, open-label run-in
- International
- Parallel-group
- Double-blind
- Placebo-controlled
- Open-label run-in
Primary result
As reported in the abstract
Hazard ratio
0.92
95% CI 0.78–1.09
P = 0.35
Events by treatment group
Spironolactone
10.46 events per 100 patient-years
258 of 1260
Placebo
11.33 per 100 patient-years
276 of 1278
Spironolactonevs Placebo
HR 0.92 (95% CI 0.78–1.09); P = 0.35
Further findings
All-cause death
- Similar between groups
- HR 0.95 [0.83-1.09]
All-cause hospitalisation
- Similar between groups
- HR 0.96 [0.87-1.06]
Original publication
Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial. Lancet. Published 16 August 2025. doi:10.
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