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Digitalis Investigation Group (DIG) Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Digitalis Investigation Group (DIG) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Digitalis Investigation Group (DIG) Clinical research trials and Digitalis Investigation Group (DIG) medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Digitalis Investigation Group (DIG). Digitalis Investigation Group (DIG) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Digitalis Investigation Group (DIG) clinical trial. Participants frequently get the best healthcare available for their Digitalis Investigation Group (DIG) condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Digitalis Investigation Group (DIG)  Digitalis Investigation Group (DIG)
Digitalis Investigation Group (DIG)
For Condition: Arrhythmia,Cardiovascular Diseases,Heart Diseases,Heart Failure, Congestive,Sinus Arrhythmia,Heart Failure
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind
Minimum Age/Maximum Age: 21 Years/75 Years
Genders: Both
Protocol Entry Criteria: Men and women with clinical heart failure, sinus rhythm, and an ejection fraction less than or equal to 45 percent.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NoCollins, , Veterans Administration Medical Center
Additional Information:
Study ID Numbers: 65;
Study Start Date: June 1990
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000476
Other Sinus Arrhythmia Studies:
1. Prevention of Early Readmission in Elderly Congestive Heart Failure Patients
2. Digitalis Investigation Group (DIG)
3. Heart Failure Adherence and Retention Trial (HART)
4. Prevalence of Asymptomatic Ventricular Dysfunction
5. Occluded Artery Trial (OAT)
Related Studies:
Other Sinus Arrhythmia Clinical Trials
Other Clinical Trials
Other Clinical Trials
Digitalis Investigation Group (DIG)
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