Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000476
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-10-27
Brief Title:
Digitalis Investigation Group DIG
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if digitalis had a beneficial harmful or no effect on total mortality in patients with clinical heart failure and sinus rhythm
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 045 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 045 492 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 life6-minute walk test substudy determined the effect of treatment on a patients well-being daily activities and functional status The Holtersignal 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
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 045 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 045 492 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 life6-minute walk test substudy determined the effect of treatment on a patients well-being daily activities and functional status The Holtersignal 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: