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Digitalis Investigation Group (DIG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000476
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.

Condition Intervention Phase
Arrhythmia Cardiovascular Diseases Heart Diseases Heart Failure, Congestive Sinus Arrhythmia Heart Failure Drug: digitalis Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1990
Study Completion Date: June 1998
Detailed 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.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women with clinical heart failure, sinus rhythm, and an ejection fraction less than or equal to 45 percent.
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: No Collins Veterans Administration Medical Center
OverallOfficial: No Fye Veterans Administration Medical Center
  More Information

Publications:
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.
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.
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.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: DIG
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.

ClinicalTrials.gov Identifier: NCT00000476     History of Changes
Other Study ID Numbers: 65
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: July 12, 2016
Last Verified: November 2005

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Arrhythmia, Sinus
Arrhythmias, Cardiac
Pathologic Processes