Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000513
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Trial of Antihypertensive Intervention Management
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:
2012-04
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:
The objective of the Trial of Antihypertensive Intervention Management TAIM was to determine the efficacy of dietary management andor drug therapy namely thiazide-like diuretics or a beta-blocker in the control of mild hypertension Additionally the Continuation of the Trial of Antihypertensive Intervention Management COTAIM tested the effects of long-term weight reduction and sodiumpotassium changes added to weight reduction as well as the original drug treatment on the failure rate of blood pressure control
Detailed Description:
BACKGROUND
The Trial of Antihypertensive Intervention Management was an extension of the NHLBI-supported Dietary Intervention Study of Hypertension DISH which concluded in March 1984 and showed that either weight reduction or sodium restriction diets reduced relapse rates of hypertensives who had received long-term drug treatment and then been withdrawn from drugs TAIM was initiated in April 1984 and continued for four years at three centers and added to DISH the art of evaluating combined drug and dietary treatments COTAIM was continued at three clinical sites in July 1988 Analysis of COTAIM results continued through November 1994 under grant R01HL40072
DESIGN NARRATIVE
TAIM patients were randomly assigned to one of three diets and to one of three drug regimens The dietary interventions consisted of a weight loss program sodium reduction with increased potassium intake or no change in diet The drug regimen consisted of a beta-blocker atenolol a thiazide-like diuretic chlorthalidone or placebo The major endpoint was change in diastolic blood pressure after six months of intervention Individuals who did not reach goal blood pressure after six months received additional drugs Other endpoints included total risk factor score change psychological function and lifestyle change
COTAIM consisted of two studies with a total of 600 subjects COTAIM I compared the TAIM weight loss group to a randomly selected half of the usual diet group The primary endpoint of COTAIM I was the degree of control of blood pressure on initial TAIM therapy between TAIM baseline and the end of COTAIM a five year period
COTAIM II added a weight loss regimen both to the sodium restrictionpotassium supplementation groups and to the other half of the usual diet group The primary outcome was control of blood pressure on initial TAIM therapy between COTAIM baseline and the end of COTAIM a two-year period
The Trial of Antihypertensive Intervention Management was an extension of the NHLBI-supported Dietary Intervention Study of Hypertension DISH which concluded in March 1984 and showed that either weight reduction or sodium restriction diets reduced relapse rates of hypertensives who had received long-term drug treatment and then been withdrawn from drugs TAIM was initiated in April 1984 and continued for four years at three centers and added to DISH the art of evaluating combined drug and dietary treatments COTAIM was continued at three clinical sites in July 1988 Analysis of COTAIM results continued through November 1994 under grant R01HL40072
DESIGN NARRATIVE
TAIM patients were randomly assigned to one of three diets and to one of three drug regimens The dietary interventions consisted of a weight loss program sodium reduction with increased potassium intake or no change in diet The drug regimen consisted of a beta-blocker atenolol a thiazide-like diuretic chlorthalidone or placebo The major endpoint was change in diastolic blood pressure after six months of intervention Individuals who did not reach goal blood pressure after six months received additional drugs Other endpoints included total risk factor score change psychological function and lifestyle change
COTAIM consisted of two studies with a total of 600 subjects COTAIM I compared the TAIM weight loss group to a randomly selected half of the usual diet group The primary endpoint of COTAIM I was the degree of control of blood pressure on initial TAIM therapy between TAIM baseline and the end of COTAIM a five year period
COTAIM II added a weight loss regimen both to the sodium restrictionpotassium supplementation groups and to the other half of the usual diet group The primary outcome was control of blood pressure on initial TAIM therapy between COTAIM baseline and the end of COTAIM a two-year period
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL030171-05 | NIH | None | httpsreporternihgovquickSearchR01HL030171-05 |