The trial finds no cardiovascular advantage and higher safety risks with spironolactone in dialysis patients

A large international study has revealed that Spironolactone. Therefore, a drug for high blood pressure and heart failure, does not reduce the risk of cardiac death or hospitalizations in people with renal failure receiving dialysis, despite smaller studies, smaller studies suggesting advantages.

The results were published on August 14 Lancet and presented at the ERA 2025 congress.

The study recruited 2. In addition, 538 participants from 143 dialysis centers in 12 countries, making it the largest trial to date in Spironolactone in people receiving dialysis. Moreover, All participants had been under dialysis for at least three months. Meanwhile, were more than 45 years old, or more than 18 years by diabetes.

In people with normal kidney function, Spironolactone reduces cardiovascular events. However. For example, people receiving dialysis may not respond in trial finds no cardiovascular advantage the same way to treatments have proven to be effective in the general population. Similarly, We launched the purchase study to determine the safety and efficiency of Spironolactone in people with kidney failure. Consequently, “”

Michael Walsh, principal researcher of the study and principal scientist at the population Health Research Institute (PHRI), a joint institute of McMaster University and Hamilton Health Sciences

The researchers tested if a low daily dose (25 mg) of Spironolactone could block aldosterone, a hormone which causes cardiac remodeling, fibrosis and increasing cardiovascular risk. Consequently, They wanted to see if this treatment could reduce the risk of cardiovascular death. hospitalization for heart failure in patients with renal failure. “Aldosterone plays a harmful role in heart disease. and its levels tend to be raised in patients with dialysis,” said Walsh. “This is why we thought that Spironolactone could help. »»

trial finds no cardiovascular advantage

Instead. the drug has not shown no cardiovascular advantage and increased the risk of severe hyperkalemia, an increase in blood potassium levels that can cause irregular cardiac rhythms or even death in extreme cases. “Previous studies have suggested that this type of medication could help people under dialysis. but they were small and had short follow -ups, unlike our major production study. »»

The trial began to recruit in 2018 and ended in December 2024. Of the 3. 565 patients recruited, 2,538 who tolerated the medication for a seven -week racing period were randomly assigned to receive 25 mg of Spironolactone daily or a placebo. The trial was arrested early for futility after an independent surveillance committee determined that there was little chance of. seeing a significant advantage.

Cardiovascular death or hospitalization for heart failure occurred in 258 patients in the group in Spironolactone, against 276 in the placebo group. trial finds no cardiovascular advantage The difference was not statistically significant. The study noted a difference in potential in these incidents between men. women, although more research is necessary to understand why:

• Hommes: 163 (spironolactone) vs 201 (placebo)
• Femmes: 95 (spironolactone) vs 75 (placebo)

Severe hyperkalemia occurred more often in the Spironolactone group: 6.6% of group patients in Spironolactone, compared to 4.5% in the placebo group. “This can be a serious security problem in an already vulnerable group,” added Walsh.

Globally, around 2.5 million people receive dialysis for kidney failure. Heart disease is the main cause of death in this population, responsible for around 40% of all deaths.

“We really hoped that the Spironolactone could make a difference for people on dialysis,” said Walsh. “Although the results are not what we wanted, they provide essential clarity. This study brings us closer to one more step to find effective. safe treatments for a group trial finds no cardiovascular advantage that needs it urgently. »»

The realization was funded by the Canadian Health Research Institutes. 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.