drugset / Trial / NCT00000476
Digitalis Investigation Group (DIG)
RandomizedDouble-blindTreatment
Summary
To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.
Timeline
- Start
- 1990-06
- Primary completion
- —
- Completion
- 1998-06
Publications
- Background Collins JF, Cline DR, Garg R, and the DIG Study Group . Protecting patient's rights: the DIG study experience. Controlled Clin Trials 1994;15:135S.
- Background Egan D, Garg R, Horney A for the Digitalis Investigation Group. Differences in patient populations between cardiovascular and noncardiovascular specialties: the DIG experience. Controlled Clin Trials 15:128S, 1994.
- Background Garg R, Yusuf S, Gorlin R on behalf of the Digitalis Investigation Group. Inclusion of patients only with low ejection fraction in heart failure trial biases the population against women and the elderly. J Am Coll Cardiol Feb, 429A, 1994.
- Background Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997 Feb 20;336(8):525-33. doi: 10.1056/NEJM199702203360801.
- Background Packer M. End of the oldest controversy in medicine. Are we ready to conclude the debate on digitalis? N Engl J Med. 1997 Feb 20;336(8):575-6. doi: 10.1056/NEJM199702203360809. No abstract available.
- Background Gheorghiade M, Pitt B. Digitalis Investigation Group (DIG) trial: a stimulus for further research. Am Heart J. 1997 Jul;134(1):3-12. doi: 10.1016/s0002-8703(97)70100-5. No abstract available.
- Background Philbin EF, Garg R, Danisa K, Denny M, Gosselin G, Hassapoyannes C, Horney A, Johnstone DE, Lang RM, Ramanathan K, Safford RE, Sarma RJ, Weiss R, Williford WO, Fleg JL. The relationship between cardiothoracic ratio and left ventricular ejection fraction in congestive heart failure. Digitalis Investigation Group. Arch Intern Med. 1998 Mar 9;158(5):501-6. doi: 10.1001/archinte.158.5.501.
- Background Hobbs RE. Digoxin's effect on mortality and hospitalization in heart failure: implications of the DIG study. Digitalis Investigation Group. Cleve Clin J Med. 1997 May;64(5):234-7. doi: 10.3949/ccjm.64.5.234. No abstract available.
- Background 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.
- Background Rich MW, McSherry F, Williford WO, Yusuf S; Digitalis Investigation Group. Effect of age on mortality, hospitalizations and response to digoxin in patients with heart failure: the DIG study. J Am Coll Cardiol. 2001 Sep;38(3):806-13. doi: 10.1016/s0735-1097(01)01442-5.
- Background Philbin EF, Hunsberger S, Garg R, Lader E, Thadani U, McSherry F, Silver MA; Digitalis Investigation Group. Usefulness of clinical information to distinguish patients with normal from those with low ejection fractions in heart failure. Am J Cardiol. 2002 May 15;89(10):1218-21. doi: 10.1016/s0002-9149(02)02311-1. No abstract available.
- Background Rathore SS, Wang Y, Krumholz HM. Sex-based differences in the effect of digoxin for the treatment of heart failure. N Engl J Med. 2002 Oct 31;347(18):1403-11. doi: 10.1056/NEJMoa021266.
- Background Fye CL, Gagne WH, Raisch DW, Jones MS, Sather MR, Buchanan SL, Chacon FR, Garg R, Yusuf S, Williford WO; DIG Investigators. The role of the pharmacy coordinating center in the DIG trial. Control Clin Trials. 2003 Dec;24(6 Suppl):289S-297S. doi: 10.1016/s0197-2456(03)00102-8.
- Background Williford WO, Collins JF, Horney A, Kirk G, McSherry F, Spence E, Stinnett S, Howell CL, Garg R, Egan D, Yusuf S; DIG Investigators. The role of the data coordinating center in the DIG trial. Control Clin Trials. 2003 Dec;24(6 Suppl):277S-288S. doi: 10.1016/s0197-2456(03)00103-x.
- Background Collins JF, Egan D, Yusuf S, Garg R, Williford WO, Geller N; DIG Investigators. Overview of the DIG trial. Control Clin Trials. 2003 Dec;24(6 Suppl):269S-276S. doi: 10.1016/s0197-2456(03)00104-1.
- Background Collins JF, Howell CL, Horney RA; Digitalis Investigation Group Investigators. Determination of vital status at the end of the DIG trial. Control Clin Trials. 2003 Dec;24(6):726-30. doi: 10.1016/j.cct.2003.08.011.
- Background Egan D, Geller N, Yusuf S, Garg R, Collins JF, Mathew J, Philbin E; DIG Investigators. Lessons learned from the DIG trial. Control Clin Trials. 2003 Dec;24(6 Suppl):316S-326S. doi: 10.1016/s0197-2456(03)00099-0.
- Background Collins JF, Martin S, Kent E, Liuni C, Garg R, Egan D; DIG Investigators. The use of regional coordinating centers in large clinical trials: the DIG trial. Control Clin Trials. 2003 Dec;24(6 Suppl):298S-305S. doi: 10.1016/s0197-2456(03)00101-6.
- Background Jones RC, Francis GS, Lauer MS. Predictors of mortality in patients with heart failure and preserved systolic function in the Digitalis Investigation Group trial. J Am Coll Cardiol. 2004 Sep 1;44(5):1025-9. doi: 10.1016/j.jacc.2004.05.077.
- Background Adams KF Jr, Patterson JH, Gattis WA, O'Connor CM, Lee CR, Schwartz TA, Gheorghiade M. Relationship of serum digoxin concentration to mortality and morbidity in women in the digitalis investigation group trial: a retrospective analysis. J Am Coll Cardiol. 2005 Aug 2;46(3):497-504. doi: 10.1016/j.jacc.2005.02.091.
- Background Mathew J, Wittes J, McSherry F, Williford W, Garg R, Probstfield J, Yusuf S; Digitalis Investigation Group. Racial differences in outcome and treatment effect in congestive heart failure. Am Heart J. 2005 Nov;150(5):968-76. doi: 10.1016/j.ahj.2005.03.060.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Digoxin | Other / unclassified | — | — |