Trial of Antihypertensive Intervention Management
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diet, reducing
diet, sodium-restricted
chlorthalidone
atenolol
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Men and women, ages 21 to 65, with mild hypertension in the range of 90 to 100 mm Hg diastolic blood pressure. Subjects were obese (110-150 percent of ideal weight).
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000513
First Posted
October 27, 1999
Last Updated
November 25, 2013
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000513
Brief Title
Trial of Antihypertensive Intervention Management
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 1984 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1994 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to determine the efficacy of dietary management and/or 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 sodium/potassium 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sodium restriction diets reduced relapse rates of hypertensives who had received long-term drug treatment and then been withdrawn from drugs.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 restriction/potassium 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
diet, reducing
Intervention Type
Behavioral
Intervention Name(s)
diet, sodium-restricted
Intervention Type
Drug
Intervention Name(s)
chlorthalidone
Intervention Type
Drug
Intervention Name(s)
atenolol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women, ages 21 to 65, with mild hypertension in the range of 90 to 100 mm Hg diastolic blood pressure.
Subjects were obese (110-150 percent of ideal weight).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morton Blaufox
Organizational Affiliation
Albert Einstein College of Medicine
First Name & Middle Initial & Last Name & Degree
Kent Kirchner
Organizational Affiliation
University of Mississippi Medical Center
First Name & Middle Initial & Last Name & Degree
Albert Oberman
Organizational Affiliation
University of Alabama at Birmingham
First Name & Middle Initial & Last Name & Degree
Sylvia Wassertheil-Smoller
Organizational Affiliation
Albert Einstein College of Medicine
12. IPD Sharing Statement
Citations:
PubMed Identifier
2649308
Citation
Davis BR, Blaufox MD, Hawkins CM, Langford HG, Oberman A, Swencionis C, Wassertheil-Smoller S, Wylie-Rosett J, Zimbaldi N. Trial of antihypertensive interventions and management. Design, methods, and selected baseline results. Control Clin Trials. 1989 Mar;10(1):11-30. doi: 10.1016/0197-2456(89)90016-0.
Results Reference
background
PubMed Identifier
2486442
Citation
Langford HG, Rockhold RW, Wassertheil-Smoller S, Oberman A, Davis BR, Blaufox MD. Effect of weight loss on thiazide produced erectile problems in men. Trans Am Clin Climatol Assoc. 1990;101:190-4.
Results Reference
background
PubMed Identifier
1967210
Citation
Oberman A, Wassertheil-Smoller S, Langford HG, Blaufox MD, Davis BR, Blaszkowski T, Zimbaldi N, Hawkins CM. Pharmacologic and nutritional treatment of mild hypertension: changes in cardiovascular risk status. Ann Intern Med. 1990 Jan 15;112(2):89-95. doi: 10.7326/0003-4819-112-2-89.
Results Reference
background
PubMed Identifier
1671380
Citation
Langford HG, Davis BR, Blaufox D, Oberman A, Wassertheil-Smoller S, Hawkins M, Zimbaldi N. Effect of drug and diet treatment of mild hypertension on diastolic blood pressure. The TAIM Research Group. Hypertension. 1991 Feb;17(2):210-7. doi: 10.1161/01.hyp.17.2.210.
Results Reference
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PubMed Identifier
2003706
Citation
Wassertheil-Smoller S, Blaufox MD, Oberman A, Davis BR, Swencionis C, Knerr MO, Hawkins CM, Langford HG. Effect of antihypertensives on sexual function and quality of life: the TAIM Study. Ann Intern Med. 1991 Apr 15;114(8):613-20. doi: 10.7326/0003-4819-114-8-613.
Results Reference
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PubMed Identifier
1986994
Citation
Langford HG. Sodium-potassium interaction in hypertension and hypertensive cardiovascular disease. Hypertension. 1991 Jan;17(1 Suppl):I155-7. doi: 10.1161/01.hyp.17.1_suppl.i155.
Results Reference
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PubMed Identifier
1728908
Citation
Wassertheil-Smoller S, Blaufox MD, Oberman AS, Langford HG, Davis BR, Wylie-Rosett J. The Trial of Antihypertensive Interventions and Management (TAIM) study. Adequate weight loss, alone and combined with drug therapy in the treatment of mild hypertension. Arch Intern Med. 1992 Jan;152(1):131-6.
Results Reference
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PubMed Identifier
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Citation
Davis BR, Oberman A, Blaufox MD, Wassertheil-Smoller S, Hawkins CM, Cutler JA, Zimbaldi N, Langford HG. Effect of antihypertensive therapy on weight loss. The Trial of Antihypertensive Interventions and Management Research Group. Hypertension. 1992 Apr;19(4):393-9. doi: 10.1161/01.hyp.19.4.393.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
Blaufox MD, Lee HB, Davis B, Oberman A, Wassertheil-Smoller S, Langford H. Renin predicts diastolic blood pressure response to nonpharmacologic and pharmacologic therapy. JAMA. 1992 Mar 4;267(9):1221-5.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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