Rationale, design, implementation, and baseline characteristics of patients in the DIG trial: a large, simple, long-term trial to evaluate the effect of digitalis on mortality in heart failure

Control Clin Trials. 1996 Feb;17(1):77-97. doi: 10.1016/0197-2456(95)00065-8.


This article provides a detailed overview of the rationale for key aspects of the protocol of the Digitalis Investigation Group (DIG) trial. It also highlights unusual aspects of the study implementation and the baseline characteristics. The DIG trial is a large, simple, international placebo-controlled trial whose primary objective is to determine the effect of digoxin on all cause mortality in patients with clinical heart failure who are in sinus rhythm and whose ejection fraction is < or = 0.45. An ancillary study examines the effect in those with an ejection fraction > 0.45. Key aspects of the trial include the simplicity of the design, broad eligibility criteria, essential data collection, and inclusion of various types of centers. A total of 302 centers in the United States and Canada enrolled 7788 patients between February 1991 and September 1993. Follow-up continued until December 1995 with the results available in Spring 1996.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial

MeSH terms

  • Aged
  • Digitalis Glycosides / therapeutic use*
  • Digoxin / therapeutic use*
  • Female
  • Heart Failure / drug therapy*
  • Heart Failure / mortality*
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic / standards
  • Patient Selection
  • Randomized Controlled Trials as Topic / standards*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Treatment Outcome


  • Digitalis Glycosides
  • Digoxin