Digitalis Investigation Group (DIG)
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| ClinicalTrials.gov Identifier: NCT00000476 |
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Recruitment Status :
Completed
First Posted : October 28, 1999
Last Update Posted : July 12, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Arrhythmia Cardiovascular Diseases Heart Diseases Heart Failure, Congestive Sinus Arrhythmia Heart Failure | Drug: digitalis | Phase 3 |
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.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Study Start Date : | June 1990 |
| Actual Study Completion Date : | June 1998 |
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| Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000476
| OverallOfficial: | No Collins | US Department of Veterans Affairs | |
| OverallOfficial: | No Fye | US Department of Veterans Affairs |
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Publications:
| ClinicalTrials.gov Identifier: | NCT00000476 |
| Other Study ID Numbers: |
65 |
| First Posted: | October 28, 1999 Key Record Dates |
| Last Update Posted: | July 12, 2016 |
| Last Verified: | November 2005 |
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Heart Failure Cardiovascular Diseases Heart Diseases |
Arrhythmias, Cardiac Arrhythmia, Sinus Pathologic Processes |