DECISION to decide on digitalis in heart failure
Digoxin is the oldest drug for heart failure (HF), and very cheap. However, digoxin is not widely prescribed as contemporary data on the efficacy of digoxin is lacking. A large trial with digoxin, the DIG trial (published in the New England Journal of Medicine in 1997), revealed a highly significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis of the DIG trial suggests that low serum concentrations of digoxin may not only reduce HF hospitalizations but also decrease mortality in patients with chronic HF. Nevertheless, a randomized, placebo-controlled trial is necessary to determine the position of digoxin in the treatment of HF, both in sinus rhythm (SR) and in atrial fibrillation (AF) .
Dirk Jan van Veldhuisen, Michiel Rienstra and Peter van der Meer from the UMCG Cardiology Research Institute received a large grant from the Dutch Cardiovascular alliance to conduct a national, multicenter, randomized, double-blind placebo controlled, clinical trial. They will determine whether a low dose of digoxin, aiming for serum concentrations 0.5-0.9 ng/mL, is beneficial in a wide spectrum of patients with HF (LVEF <50%). The primary objective is to study whether in chronic HF compared to placebo, low-level digoxin reduces (repeated) HF hospitalizations and cardiovascular mortality, on top of guideline-recommended therapies. We will include an estimated 982 chronic HF patients with LVEF <50%, with at least 1/3 of patients with AF, and 1/3 women, to ensure a sample of the real life HF population. First patient is expected to be enrolled in May 2020.
This is the first randomized clinical trial (RCT) with digoxin in HF patients with sinus rhythm in 25 years, and the first RCT ever in HF patients with AF. The results of DECISION will impact HF Guidelines.
“Studying digoxin in a new trial with state-of-the-art analyses and modern perspective might provide exciting new data from the oldest heart failure drug.”
