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Trial NCT00000476

Resource URI: http://static.linkedct.org/resource/trials/NCT00000476
PropertyValue
linkedct:brief_title Digitalis Investigation Group (DIG)
linkedct:condition <http://static.linkedct.org/resource/condition/1156>
linkedct:condition <http://static.linkedct.org/resource/condition/12112>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/5704>
linkedct:condition <http://static.linkedct.org/resource/condition/5709>
linkedct:criteria Men and women with clinical heart failure, sinus rhythm, and an ejection fraction less than or equal to 45 percent.
linkedct:description BACKGROUND: Despite widespread use of digitalis and its availability for nearly two centuries, uncertainty surrounded the appropriateness of its role and value in treating congestive heart failure patients in sinus rhythm. The study was a multicenter collaborative effort with the Department of Veteran Affairs Cooperative Studies Program which provided support for a data coordinating center and a pharmacy coordinating center. DESIGN NARRATIVE: Randomized, double-blind, simple, multicenter, international trial with 186 centers in the United States and 116 in Canada. In the main trial, patients with left ventricular ejection fractions of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and ACE inhibitors. In an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo. Patients were recruited over a three-year period at the 302 centers and followed for a minimum of two years. Patient enrollment began in February 1991 and ended in September 1993. Follow-up ended in December 1995. The main results paper was published in 1997. Three substudies were conducted. The quality of life/6-minute walk test substudy determined the effect of treatment on a patient's well-being, daily activities, and functional status. The Holter/signal averaging electrocardiogram substudy examined the pathophysiology of sudden cardiac death. The neurohormonal substudy determined whether long-term administration of digoxin attenuated the neuroendocrine response in patients with heart failure.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 21 Years
linkedct:end_date June 1998
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000476
rdfs:label Trial NCT00000476
linkedct:lastchanged_date December 1, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000476
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 65
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/43966>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/43967>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000476>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/1053>
linkedct:reference <http://static.linkedct.org/resource/reference/11108>
linkedct:reference <http://static.linkedct.org/resource/reference/1330>
linkedct:reference <http://static.linkedct.org/resource/reference/13469>
linkedct:reference <http://static.linkedct.org/resource/reference/15240>
linkedct:reference <http://static.linkedct.org/resource/reference/20159>
linkedct:reference <http://static.linkedct.org/resource/reference/20160>
linkedct:reference <http://static.linkedct.org/resource/reference/20161>
linkedct:reference <http://static.linkedct.org/resource/reference/20162>
linkedct:reference <http://static.linkedct.org/resource/reference/20163>
linkedct:reference <http://static.linkedct.org/resource/reference/20273>
linkedct:reference <http://static.linkedct.org/resource/reference/23553>
linkedct:reference <http://static.linkedct.org/resource/reference/27936>
linkedct:reference <http://static.linkedct.org/resource/reference/29133>
linkedct:reference <http://static.linkedct.org/resource/reference/50247>
linkedct:reference <http://static.linkedct.org/resource/reference/51575>
linkedct:reference <http://static.linkedct.org/resource/reference/51638>
linkedct:reference <http://static.linkedct.org/resource/reference/52224>
linkedct:reference <http://static.linkedct.org/resource/reference/52806>
linkedct:reference <http://static.linkedct.org/resource/reference/53995>
linkedct:reference <http://static.linkedct.org/resource/reference/773>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date June 1990
linkedct:study_design Treatment, Randomized, Double-Blind
linkedct:study_type Interventional
linkedct:summary To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.
rdf:type linkedct:trials
linkedct:verification_date November 2005