|
Digitalis Investigation Group (DIG) Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD 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 take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Digitalis Investigation Group (DIG). Digitalis Investigation Group (DIG) Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Digitalis Investigation Group (DIG) clinical trial. Test subjects typically obtain the finest healthcare available for their Digitalis Investigation Group (DIG) condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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 Heart Failure Studies:
1. Multicenter Study of Silent Myocardial Ischemia (MSSMI)
2. Epidemiology of Carotid Disease in Elderly Adults
3. High Blood Pressure in the Young
4. Genetic Analysis of Human Hypertensive End Stage Renal Disease (H-ESRD)
5. Occluded Artery Trial (OAT)
Related Studies:
Other Heart Failure Clinical Trials
Other Clinical Trials
Other Clinical Trials
Digitalis Investigation Group (DIG)
|
|
|
|
|
|
|
|
