The aim of this study is to address unresolved issues in the long- term therapy of mild hypertension by continuing the treatment and follow-up of participants enrolled in the Trial of Antihypertensive Interventions and Management (TAIM).
T AIM i s a multicenter, randomized, placebo-controlled trial designed to assess the effectiveness of various combinations of pharmacologic and dietary interventions in the treatment of mild hypertension (DBP 90-100 mmHg). The primary endpoint is blood pressure change between baseline and six months. The study consists of a 3 X 3 factorial design wherein participants are randomly allocated to 9 drug-diet treatment groups. Drugs include placebo, diuretic and bets- blocker. Diets are usual, weight loss and low sodium/high potassium (Na+/K+). The basic strategy is to address clinical questions of interest by comparing mean DBP changes of selected diet-drug combinations. Secondary objectives are to assess for each selected combination: 1) changes in serum and urine chemistries; 2) change in quality of life measures and well-being (including assessment of side effects), and 3) change in cardiovascular risk score. In preliminary TAIM analyses, weight loss appears to substantially lower DBP at 6 months when compared to a usual or Na+/K+ diet. There appear to be no blood pressure differences between the Na+/K+ and usual diet groups. In the continuation of TAIM (COTAIM), the weight loss group and a randomly selected half of the usual diet group are to be followed without change to evaluate the long-term efficacy of weight loss in the control of mild hypertension. The weight loss regimen is to be added to the Na+/K+ group and the other randomly selected half of the usual diet group during a six month enrollment period to evaluate possible additive effects of weight loss and sodium restriction in comparison to weight loss alone.
COT AIM proposes to assess the effectiveness of these various treatments by comparing the proportion successful in blood pressure control on initial drug therapy. In addition, changes in cardiovascular risk scores and quality of life indices for selected antihypertensive interventions will be analyzed. The periods of follow-up will average about 5 years for the weight loss-usual diet comparison, including the TAIM follow-up, and 2 years for the weight loss-weight loss/sodium restriction comparison.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
2R01HL030171-05A1
Application #
3341219
Study Section
(SRC)
Project Start
1984-04-01
Project End
1991-06-30
Budget Start
1988-07-01
Budget End
1989-06-30
Support Year
5
Fiscal Year
1988
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
Schools of Medicine
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Davis, B R; Oberman, A; Blaufox, M D et al. (1994) Lack of effectiveness of a low-sodium/high-potassium diet in reducing antihypertensive medication requirements in overweight persons with mild hypertension. TAIM Research Group. Trial of Antihypertensive Interventions and Management. Am J Hypertens 7:926-32
Davis, B R; Blaufox, M D; Oberman, A et al. (1993) Reduction in long-term antihypertensive medication requirements. Effects of weight reduction by dietary intervention in overweight persons with mild hypertension. Arch Intern Med 153:1773-82
Davis, B R; Oberman, A; Blaufox, M D et al. (1992) Effect of antihypertensive therapy on weight loss. The Trial of Antihypertensive Interventions and Management Research Group. Hypertension 19:393-9
Wassertheil-Smoller, S; Blaufox, M D; Oberman, A et al. (1991) Effect of antihypertensives on sexual function and quality of life: the TAIM Study. Ann Intern Med 114:613-20
Langford, H G; Davis, B R; Blaufox, D et al. (1991) Effect of drug and diet treatment of mild hypertension on diastolic blood pressure. The TAIM Research Group. Hypertension 17:210-7
Langford, H G; Rockhold, R W; Wassertheil-Smoller, S et al. (1990) Effect of weight loss on thiazide produced erectile problems in men. Trans Am Clin Climatol Assoc 101:190-4
Oberman, A; Wassertheil-Smoller, S; Langford, H G et al. (1990) Pharmacologic and nutritional treatment of mild hypertension: changes in cardiovascular risk status. Ann Intern Med 112:89-95