Heart Failure Clinical Trial
To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.
BACKGROUND:
Despite widespread use of digitalis and its availability for nearly two centuries,
uncertainty surrounded the appropriateness of its role and value in treating congestive
heart failure patients in sinus rhythm. The study was a multicenter collaborative effort
with the Department of Veteran Affairs Cooperative Studies Program which provided support
for a data coordinating center and a pharmacy coordinating center.
DESIGN NARRATIVE:
Randomized, double-blind, simple, multicenter, international trial with 186 centers in the
United States and 116 in Canada. In the main trial, patients with left ventricular ejection
fractions of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403
patients) in addition to diuretics and ACE inhibitors. In an ancillary trial of patients
with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin
and 496 to placebo. Patients were recruited over a three-year period at the 302 centers and
followed for a minimum of two years. Patient enrollment began in February 1991 and ended in
September 1993. Follow-up ended in December 1995. The main results paper was published in
1997.
Three substudies were conducted. The quality of life/6-minute walk test substudy determined
the effect of treatment on a patient's well-being, daily activities, and functional status.
The Holter/signal averaging electrocardiogram substudy examined the pathophysiology of
sudden cardiac death. The neurohormonal substudy determined whether long-term administration
of digoxin attenuated the neuroendocrine response in patients with heart failure.
The study completion date listed in this record was obtained from the "Completed Date"
entered in the Query View Report System (QVR).
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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