NEED FOR A LARGE RANDOMIZED TRIAL TO EVALUATE THE EFFECTS OF DIGITALIS ON MORBIDITY AND MORTALITY IN CONGESTIVE-HEART-FAILURE

Despite major advances in the prevention and treatment of cardiovascular diseases, the incidence and prevalence af congestive heart failure (CHF) have been increasing in recent years. As the average age of the population increases, the prevalence of CHF is expected to continue to increase. The number deaths in which CHF was considered the underlying or contributing increased from 51,000 in 1955 to 274,000 by 1988 in the United States. Even accounting for population growth and an increase in the number of elderly, this represents a 2-fold increase. Additionally, CHF was responsible for about 643,000 hospitalizations in 1988. Digitalis is one of the drugs most commonly prescribed for CHF and has been used for >200 years. In 1990, digoxin was one of the most commonly prescribed drugs in the United States, accounting for > 21 million prescriptions. There has been little decline in the drug's use over the last 5 years, indicating that newer treatments for CHF have not replaced the widespread use of digitalis. Despite these findings, considerable controversy surrounds the appropriateness of its role and value in treating CHF patients who are in sinus rhythm. A number af recent, uncontrolled studies have arrived at apparently contradictory conclusions concerning the effects of digitalis on mortality in postmyocardial infarction and heart failure patients. A large, double-blind, randomized, controlled clinical trial to evaluate the effects of digitalis on mortality, morbidity and quality of life is being sponsored by the National Heart, Lung, and Institute in conjunction with the Department of Veterans Affairs Cooperative Studies Program. Patients with CHF and an ejection fraction less-than-or-equal-to 0.45 will be randomized to receive digoxin or placebo along with other standard therapy. Patients with an ejection fraction >0.45 also will be enrolled in a parallel but separate ancillary study. Patient recruitment started in early March 1991, and about 7,500 to 8,000 patients are expected to be enrolled over 3 years and followed for a minimum of 2 further years or until the end of the study. Results are expected to become available in 1995 or 1996.