The randomised Aldactone evaluation study (RALES)20
| Purpose | To evaluate whether treatment with 25 mg spironolactone per day can diminish total mortality in patients with severe cardiac insufficiency secondary to systolic dysfunction who are under standard treatment including angiotensin converting enzyme (ACE) inhibitor when the patient tolerated it. |
| Design | A multi-site, double blind randomised clinical trial |
| Countries | Belgium, Brazil, Canada, France, Germany, Japan, Mexico, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom, USA, and Venezuela. |
| Population | 1663 Patients with severe chronic heart failure (CHF). Four countries enrolled more than 100 patients with a 68% of total sample (n = 1138). Twelve countries enrolled less than 100 patients with a 32% of total sample (n = 525). |
| Treatment being studied | Patients were randomised to 25 mg spironolactone (n = 822) or placebo (n = 841). After an eight week follow up the dose could be increased to 50 mg/day if progression of the cardiac insufficiency was observed without evidence of hyperkalaemia (K>6 mmol/l). If hyperkalaemia appeared, the dose of spironolactone could be reduced to 25 mg/48 h, although previous adjustment of the dose of other pharmaceuticals was recommended. Monthly evaluations were carried out during the first three months, three monthly evaluations during the first year, and after that, every six months. |
| Primary objective | Death due to any cause. Secondary objectives: death of cardiovascular origin, hospitalisation for cardiovascular cause, combination of the two previous causes. Changes in the NYHA class. |
| Analysis | For the intention of trying. Average follow up, two years. The study was detained when efficacy in the spironolactone group was shown. |
| Results | Reduction of mortality by 30% (RR = 0.70; 95% CI = 0.60 to 0.82; p<0.001). Reduction of hospitalisation for heart failure by 35% (RR = 0.65; 95% CI = 0.54 to 0.77; p<0.001) |