Although
therapy with
mineralocorticoid receptor antagonists (MRAs) is recommended for patients with chronic
heart failure (HF) with reduced ejection fraction and in post-
infarction HF, it has not been studied well in acute HF (AHF) despite being commonly used in this setting. At high doses, MRA
therapy in AHF may relieve congestion through its natriuretic properties and mitigate the effects of adverse neurohormonal activation associated with intravenous
loop diuretics. The ATHENA-HF (
Aldosterone Targeted Neurohormonal Combined with Natriuresis
Therapy in
Heart Failure) trial is a randomized, double-blind, placebo-controlled study of the safety and efficacy of 100 mg/day
spironolactone versus placebo (or continued low-dose
spironolactone use in participants who are already receiving
spironolactone at baseline) in 360 patients hospitalized for AHF. Patients are randomized within 24 h of receiving the first dose of intravenous
diuretics. The primary objective is to determine if high-dose
spironolactone, compared with standard care, will lead to greater reductions in N-terminal pro-
B-type natriuretic peptide levels from randomization to 96 h. The secondary endpoints include changes in the clinical congestion score,
dyspnea relief, urine output, weight change,
loop diuretic dose, and in-hospital worsening HF. Index hospital
length of stay and 30-day clinical outcomes will be assessed. Safety endpoints include risk of
hyperkalemia and renal function. Differences among patients with reduced versus preserved ejection fraction will be determined. (Study of High-dose
Spironolactone vs. Placebo
Therapy in Acute Heart Failure [ATHENA-HF]; NCT02235077).