Overview of the DIG trial

Control Clin Trials. 2003 Dec;24(6 Suppl):269S-276S. doi: 10.1016/s0197-2456(03)00104-1.


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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Canada
  • Cardiotonic Agents / therapeutic use
  • Digoxin / therapeutic use
  • Heart Failure / drug therapy
  • Humans
  • Multicenter Studies as Topic / methods*
  • Organization and Administration*
  • Randomized Controlled Trials as Topic / methods*
  • Research Design
  • United States


  • Cardiotonic Agents
  • Digoxin