Hospitalization for heart failure, (HF), represents a major health problem with high rates of death or early readmission after discharge. The aim of this study was to investigate whether aliskiren, (a direct renin inhibitor), added to standard therapy can reduce the rate of cardiovascular death or re-hospitalization in patients with HF. The study was double-blind and placebo-controlled, in which hemodynamically stable patients with heart failure were randomized approximately five days after admission. Eligible patients had ejection fraction, (EF), of 40% or less, had elevated natriuretic peptides, ([BNP] ≥ 400 pg/ml or N-terminal pro-BNP [NT-proBNP] ≥ 1600 pg/ml), and had signs and symptoms of congestion. Patients were enrolled at 316 sites across North and South America, Europe and Asia between May 2009 and December 2011. The monitoring period ended in July 2012. All patients received 150 mg, (up to 300 mg as tolerated), of aliskiren daily or a placebo in addition to standard therapy. The study drug was continued after discharge for a median of 11.3 months.
In total, the ASTRONAUT study included 1,639 patients that were randomized. At twelve months the event rate was 35% for the aliskiren group, (126 CV deaths, readmissions HF 212), and 37.3% for the placebo group, (137 HP, 224 deaths readmissions IC, RH, 0, 93, 95% CI, 0.79 to 1.09, P = 0.36). The rates of hyperkalaemia, hypotension and renal failure were higher in the aliskiren group compared with the placebo group.
The study found that among hospitalized patients for heart failure with reduced ejection fraction, indicating aliskiren when added to standard therapy for heart failure did not reduce cardiovascular death or re-hospitalization for heart failure, either at six or twelve months after discharge.
Mihai Gheorghiade
2013-03-11
Original title: The ASTRONAUT Study: Aliskiren Trial On Acute Heart Failure Outcomes.
