Genre
- Journal Article
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 less than or equal to 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.
ST JOSEPHS HOSP,TAMPA,FL. UNIV NEW MEXICO,SCH MED,ALBUQUERQUE,NM 87131. VAMC,TOPEKA,KS. SINAI SAMARITAN MED CTR,MILWAUKEE,WI. VAMC,PITTSBURGH,PA. VAMC,MINNEAPOLIS,MN. VICTORIA HOSP,LONDON,ON N6A 4G5,CANADA. PENTICTON REG HOSP,PENTICTON,BC,CANADA(TRUNCATED)
NEW YORK; 655 AVENUE OF THE AMERICAS, NEW YORK, NY 10010
ELSEVIER SCIENCE INC
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Source type: Electronic(1)
Language
- English
Subjects
- randomized clinical trial
- heart failure
- large simple trial
- Pharmacology & Pharmacy
- digoxin
- CLINICAL-TRIALS
- Medicine, Research & Experimental
- DESIGN
- NEED