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RALES study

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

  • randomised double-blind controlled trial

  • patients involved in the study had severe heart failure (New York Heart Association Class IV) - all patients were being treated with a loop diuretic; most were also being treated with an ACE inhibitor. The ejection fraction of patients was less than 35%

  • patients were randomised to placebo or spironolactone 25-50mg - other treatments were continued. Potassium levels were monitored regularly throughout the study. The dose of spironolactone was increased to 50mg after one month if serum potassium level allowed

  • 1663 patients with severe heart failure were recruited to the study and the mean follow up was 24 months

  • in the spironolactone treatment group there was a 30% reduction in all-cause mortality, lowered hospitalisation rates and improved symptomatic control

  • the incidence of serious hyperkalaemia was uncommon - 1% in the placebo group and 2% in the spironolactone treatment group

Reference:

  • NEJM (1999), 341, 709-17.

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