Spironolactone in patients on chronic haemodialysis at high risk of adverse cardiovascular outcomes (ALCHEMIST): a multicentre, double-blind, randomised, placebo-controlled trial and updated meta-analysis
Errata to this article were published (Lancet, 11 Oct 2025 ↗ · 31 Jan 2026 ↗)
Pooled resultResult — go to the resultHazard ratio 1.00 95% CI 0.73–1.36- stopped prematurely
- Trial stopped prematurely
Authors' conclusion
In patients with kidney failure on haemodialysis and with high risk of adverse cardiovascular outcomes, spironolactone did not reduce the incidence of major cardiovascular events.
Study context
- Population
- Adults with kidney failure on chronic haemodialysis with ≥1 CV comorbidity or risk factor; 64 centres in France, Belgium and Monacorandomly assigned
- Participants
- 644 adults
- Comparison
- Spironolactone vs placebo
- Spironolactonen = 320
- Placebon = 324reference
- Outcome
- Time to first MACE:
- CV death
- Non-fatal MI
- ACS
- Stroke
- Hospitalisation for HF
- Follow-up
- Median 32.6 months
Methodological detailsinvestigator-initiated, multicentre, double-blind, placebo-controlled, event-driven, 4-week open-label run-in
- Investigator-initiated
- Multicentre
- Double-blind
- Placebo-controlled
- Event-driven
- 4-week open-label run-in
Pooled result
As reported in the abstract
Hazard ratio
1.00
95% CI 0.73–1.36
P = 0.98
Events by group
Spironolactonevs Placebo
HR 1.00 (95% CI 0.73–1.36); P = 0.98
Further pooled results
Meta-analysis of MRA RCTs in haemodialysis: all-cause mortality, CV mortality, non-fatal CV events
- MRAs did not reduce all-cause or CV mortality or non-fatal CV events
Safety
| Outcome | Spironolactone | Placebo | HR (95% CI) | |
|---|---|---|---|---|
| Hyperkalaemia >6 mmol/L | 42% | 41% | 1.12 (0.88–1.43) | |
| 0.512Hazard ratio (log scale) |
Hyperkalaemia >6 mmol/L
- Meta-analysis: MRAs did not increase the odds of hyperkalaemia (serum potassium >6 mmol/L)
Original publication
Spironolactone in patients on chronic haemodialysis at high risk of adverse cardiovascular outcomes (ALCHEMIST): a multicentre, double-blind, randomised, placebo-controlled trial and updated meta-analysis. Lancet. Published 16 August 2025. doi:10. 1016/ s0140-6736(25)01194-8
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