Patients with acute heart failure often have high natriuretic peptide levels, and high doses of mineralocorticoid receptor antagonists are known to relieve congestion and overcome diuretic resistance. The objective of this research is to evaluate the effect of high-dose spironolactone and usual care for patients with high NT-proBNP levels compared to usual care alone.
This is a double-blind and placebo-controlled randomized clinical trial conducted in 22 US acute care hospitals. It included a total of 360 patients with AHF who were previously receiving no or low dose of spironolactone and had NT-proBNP levels higher than 1000 pg/mL. High-dose spironolactone (100 mg) was given to one group of patients and the usual care (25 mg spironolactone) to others daily for 96 hours.
The group treated with high-dose spironolactone had a baseline median NT-proBNP of 4601 pg/mL, compared to 3,753 pg/mL among the group that received usual care. There was no difference in all-cause mortality or heart failure hospitalization rate among the two groups. The changes in serum potassium and estimated glomerular filtration rate were also similar between the two groups.
The research concluded that adding treatment with high-dose spironolactone to usual care for patients was well tolerated, but it did not improve the efficiency endpoints.