The efficacy of digoxin, particularly its effect on mortality, in patients with congestive heart failure in normal sinus rhythm has been debated for years. This large, randomized, placebo-controlled study was designed to look at the effect of digoxin on mortality and on hospitalization. Subjects were patients with congestive heart failure designated by symptoms, signs or chest x-ray in normal sinus rhythm. Treatment with digoxin was not a reason for exclusion. Patients were enrolled from 302 centers in the United States and Canada.
Between February 1991 and August 1993 patients were randomized to either digoxin or placebo. Patients were followed up every four months.
The primary endpoint was mortality. Secondary outcomes included cardiovascular mortality, death from worsening congestive heart failure, hospitalization for congestive heart failure, and hospitalization for other causes.
In the main trial, 3,397 patients were assigned to digoxin, 3,403 to a placebo. Mean duration of follow-up was 37 months.
There was no significant difference in the number of deaths between the two groups - 1,181 in the digoxin group (34.8%), vs. 1,194 in the placebo group (35.1%). Most of these deaths were cardiovascular (1,016 and 1,004, respectively). There was a strong trend towards lower mortality from worsening congestive heart failure in the digoxin group.
In the digoxin group, there were fewer hospitalizations for worsening heart failure as well as fewer patients hospitalized for worsening heart failure.
Read the study for more in depth information.
