Trial Finds No Cardiovascular Benefit And Higher Safety Risks With Spironolactone In Dialysis Patients

A ample world study has recovered that spironolactone, a medicine for precocious humor unit and bosom failure, does not trim nan consequence of heart-related decease aliases hospitalizations successful group pinch kidney nonaccomplishment receiving dialysis, contempt earlier smaller studies suggesting benefit.

The findings were published connected August 14 successful The Lancet and presented astatine ERA Congress 2025.

The study enrolled 2,538 participants from 143 dialysis centres crossed 12 countries, making it nan largest proceedings to day connected spironolactone successful group receiving dialysis. All participants had been connected dialysis for astatine slightest 3 months and were either complete 45 years old, aliases complete 18 pinch diabetes.

In group pinch normal kidney function, spironolactone reduces cardiovascular events. However, group receiving dialysis mightiness not respond nan aforesaid measurement to treatments proven effective successful nan wide population. We launched nan ACHIEVE study to find nan information and effectiveness of spironolactone successful group pinch kidney failure."

Michael Walsh, main interrogator of nan study and elder intelligence astatine nan Population Health Research Institute (PHRI), a associated institute of McMaster University and Hamilton Health Sciences

Researchers tested whether a debased regular dose (25 mg) of spironolactone could artifact aldosterone, a hormone that causes bosom remodeling, fibrosis, and raises cardiovascular risk. They wanted to spot if this curen could little nan consequence of cardiovascular decease aliases hospitalization for bosom nonaccomplishment successful patients pinch kidney failure. "Aldosterone plays a harmful domiciled successful bosom disease, and its levels thin to beryllium precocious successful dialysis patients," Walsh said. "That's why we thought spironolactone mightiness help."

Instead, nan supplier showed nary cardiovascular benefit, and it accrued nan consequence of terrible hyperkalaemia, a emergence successful humor potassium levels that tin lead to irregular bosom rhythms aliases moreover decease successful utmost cases. "Earlier studies suggested this type of medicine mightiness thief group connected dialysis, but they were mini and had short follow-ups, dissimilar our ample ACHIEVE study."

The proceedings began recruiting successful 2018 and concluded successful December 2024. Of nan 3,565 patients recruited, 2,538 who tolerated nan supplier during a seven-week run-in play were randomly assigned to person either 25 mg of spironolactone regular aliases a placebo. The proceedings was stopped early for futility aft an independent monitoring committee wished location was small chance of seeing a meaningful benefit.

Cardiovascular decease aliases hospitalization for bosom nonaccomplishment occurred successful 258 patients successful nan spironolactone group, compared to 276 successful nan placebo group. The quality was not statistically significant. The study noted a imaginable quality successful these incidents betwixt men and women, though much investigation is needed to understand why:

• Men: 163 (spironolactone) vs. 201 (placebo)
• Women: 95 (spironolactone) vs. 75 (placebo)

Severe hyperkalaemia occurred much often successful nan spironolactone group: 6.6 per cent of patients successful nan spironolactone group, compared to 4.5 per cent successful nan placebo group. "This tin beryllium a superior information interest successful an already susceptible group," Walsh added.

Globally, an estimated 2.5 cardinal group person dialysis for kidney failure. Heart illness is nan starring origin of decease successful this population, responsible for astir 40 per cent of each deaths.

"We really hoped that spironolactone could make a quality for group connected dialysis," said Walsh. "While nan results are not what we wanted, they supply much-needed clarity. This study moves america 1 measurement person to uncovering effective and safe treatments for a group that urgently needs them."

ACHIEVE was funded by nan Canadian Institutes of Health Research, Medical Research Future Fund, Health Research Council, British Heart Foundation, PHRI, St. Joseph's Healthcare Hamilton, Accelerating Clinical Trials Canada, CanSOLVE CKD, and Dalhousie Department of Medicine.