Overview of the DIG trial.
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.
Collins
Joseph F
JF
Department of Veterans Affairs, Cooperative Studies Program, Perry Point, Maryland 21902, USA. joseph.collins2@med.va.gov
Egan
Debra
D
Yusuf
Salim
S
Garg
Rekha
R
Williford
William O
WO
Geller
Nancy
N
D002170:Canada; D002316:Cardiotonic Agents / Q000627:therapeutic use; D004077:Digoxin / Q000627:therapeutic use; D006333:Heart Failure / Q000188:drug therapy; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D009934:Organization and Administration; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D014481:United States
D002316:Cardiotonic Agents; D004077:Digoxin