Low-dose digoxin in patients with heart failure with reduced or mildly reduced ejection fraction: a randomized controlled trial

Digoxin is the oldest drug in cardiovascular medicine, but its value in the current management of heart failure is unclear. Earlier studies have suggested that low-dose digoxin might be beneficial, but evidence from rigorous randomized clinical trials is lacking.

In this double-blind, placebo-controlled trial (the DECISION trial), 1,001 patients with symptomatic chronic heart failure and a left ventricular ejection fraction of 50% or less were randomized to low-dose digoxin or placebo, with a target serum digoxin concentration of 0.5–0.9 ng ml −1 . The mean age of the participants was 72 ± 9 years, 28% were women and 29% had atrial fibrillation.

The primary outcome was a composite of total worsening heart failure events, defined as total hospitalizations or total urgent hospital visits for worsening heart failure and cardiovascular mortality. Over a median follow-up of 36.5 months, 238 primary-outcome events occurred in 131 of 500 patients in the digoxin group, and 291 primary-outcome events in 152 of 501 patients occurred in the placebo group (rate ratio 0.81; 95% confidence interval (CI) 0.61–1.07, P = 0.133).