Cardiometabolic & kidney

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

LancetPublished Randomised 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

OutcomeSpironolactonePlaceboHR (95% CI)
Hyperkalaemia >6 mmol/L42%41%1.12 (0.88–1.43)

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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