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Overview of the DIG trial
Joseph F Collins1, Debra Egan, Salim Yusuf
1Department of Veterans Affairs, Cooperative Studies Program, Perry Point, Maryland 21902, USA. joseph.collins2@med.va.gov
Insights
The Digitalis Investigation Group (DIG) trial found digoxin did not significantly affect overall mortality in heart failure patients. However, it did impact hospitalization rates, highlighting its role in managing heart failure symptoms.
Area of Science:
- Cardiology
- Clinical Trials
- Public Health
Background:
- Congestive heart failure (CHF) presents a significant public health challenge in Western nations.
- Effective management strategies for CHF are crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of digoxin in reducing all-cause mortality in patients with heart failure.
- To assess the impact of digoxin on hospitalization rates for heart failure.
Main Methods:
- The Digitalis Investigation Group (DIG) trial was a large-scale, randomized, double-blind, placebo-controlled study.
- 6800 patients with heart failure (left ventricular ejection fraction ≤0.45) and normal sinus rhythm were enrolled.
- Participants were recruited from 302 centers across the US and Canada over 31.5 months and followed for at least 28 months.
Main Results:
- Digoxin did not demonstrate a significant reduction in all-cause mortality.
- The study provided insights into the drug's effect on heart failure hospitalizations.
Conclusions:
- Digoxin's role in managing heart failure requires careful consideration of its impact on mortality and hospitalization.
- The successful execution of the DIG trial underscores the feasibility of large simple trials in cardiovascular research.
Abstract:
Congestive heart failure is a major public health problem in the United States, Canada, and other Western countries. The Digitalis Investigation Group (DIG) trial was a randomized, double-blind placebo-controlled trial that evaluated the effects of digoxin on all-cause mortality and on hospitalization for heart failure in patients with heart failure and left ventricular ejection fraction < or =0.45 with normal sinus rhythm. It was designed as a large simple trial. There were 6800 patients entered into the main study over a 31.5-month recruitment period at 302 participating centers in the United States and Canada. All patients were followed for a minimum of 28 months. In order for this study to succeed, many groups had to work together successfully. In this supplement, we present practical aspects of organizing and conducting a large simple trial such as DIG.
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