title: Overview of the DIG trial.
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.
authors.affiliation: Department of Veterans Affairs, Cooperative Studies Program, Perry Point, Maryland 21902, USA. joseph.collins2@med.va.gov
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Collins
authors.forename: Debra
authors.initials: D
authors.lastname: Egan
authors.forename: Salim
authors.initials: S
authors.lastname: Yusuf
authors.forename: Rekha
authors.initials: R
authors.lastname: Garg
authors.forename: William O
authors.initials: WO
authors.lastname: Williford
authors.forename: Nancy
authors.initials: N
authors.lastname: Geller
mesh_terms: 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
chemical_list: D002316:Cardiotonic Agents; D004077:Digoxin