Related Experiment Videos
Need for a large randomized trial to evaluate the effects of digitalis on morbidity and mortality in congestive heart
1Clinical Trials Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland 20892.
Insights
Congestive heart failure (CHF) is increasing, yet the role of digitalis in treating patients with sinus rhythm remains controversial. A large clinical trial is underway to clarify digitalis
Area of Science:
- Cardiology
- Pharmacology
Background:
- Congestive heart failure (CHF) incidence and prevalence are rising, particularly with an aging population.
- CHF significantly contributes to mortality and hospitalizations in the United States.
- Digitalis, including digoxin, remains a widely prescribed medication for CHF despite over 200 years of use.
Purpose of the Study:
- To evaluate the effects of digitalis on mortality, morbidity, and quality of life in CHF patients.
- To address the controversy surrounding the appropriateness of digitalis in treating CHF patients in sinus rhythm.
Main Methods:
- A large-scale, double-blind, randomized, controlled clinical trial.
- Sponsored by the National Heart, Lung, and Blood Institute and the Department of Veterans Affairs Cooperative Studies Program.
Main Results:
- Contradictory conclusions from recent uncontrolled studies regarding digitalis' effects on mortality.
- Ongoing clinical trial to provide definitive evidence.
Conclusions:
- The precise role and value of digitalis in CHF patients with sinus rhythm require further investigation.
- A major clinical trial is expected to resolve existing controversies.
Abstract:
Despite major advances in the prevention and treatment of cardiovascular diseases, the incidence and prevalence of 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 of deaths in which CHF was considered the underlying or contributing cause 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 greater than 200 years. In 1990, digoxin was one of the most commonly prescribed drugs in the United States, accounting for greater than 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 of 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 Blood Institute in conjunction with the Department of Veterans Affairs Cooperative Studies Program.(ABSTRACT TRUNCATED AT 250 WORDS)