TRIAL OF ANTIHYPERTENSIVE INTERVENTIONS AND MANAGEMENT

抗高血压干预和管理试验

• 批准号: 3357129
• 负责人: BARRY R DAVIS
• 金额: $ 56.66万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-07-01 至 1992-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3357129
• 关键词: African American; antihypertensive agents; beta antiadrenergic agent; blood chemistry; cardiovascular disorder chemotherapy; caucasian American; disease /disorder proneness /risk; diuretics; health care cost /financing; human subject; human therapy evaluation; hypertension; longitudinal human study; low salt diet; nutrition related tag; reducing diet; urinalysis

The aim of this study is to address unresolved issues in the long- term therapy of mild hypertension of continuing the treatment and follow-up of participants enrolled in the Trial of Antihypertensive Interventions and Management (TAIM). TAIM is 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 beta-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. COTAIM 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.

这项研究的目的是解决长期悬而未决的问题- 持续治疗的轻度高血压长期治疗 参加试验的受试者的随访情况 抗高血压干预和管理（TAIM）。 TAIM是 一项多中心、随机、安慰剂对照试验， 评估各种药物组合的有效性 饮食干预治疗轻度高血压 (DBP 90-100 mmHg）。 主要终点是血压 基线和6个月之间的变化。 本研究包括 3 × 3析因设计，其中参与者被随机分配 9个药物饮食治疗组。 药物包括安慰剂利尿剂 和β-受体阻滞剂 饮食是正常的，减肥和低 钠/高钾（Na+/K+）。 基本战略是解决 关注的临床问题，通过比较 选择的饮食药物组合。 次要目的是 评估每种选择的组合：1）血清和 尿化学; 2）生活质量指标的变化，以及 （包括副作用的评估），以及3） 心血管风险评分。 在初步的TAIM分析中，体重减轻似乎实质上 与常规或Na+/K+饮食相比，6个月时DBP较低。 两组之间似乎没有血压差异， Na+/K+和普通饮食组。 在TAIM的延续中 （COTAIM），减肥组和随机选择的一半 按照常规饮食组进行评价 减肥对控制轻度肥胖的长期疗效 高血压 减肥方案将被添加到 Na+/K+组与另一组随机抽取平时的一半 饮食组在六个月的招募期间， 体重减轻和钠限制可能的叠加效应， 与单独减肥相比。 COTAIM建议评估 通过比较这些不同治疗方法的有效性， 使用初始药物成功控制血压的比例 疗法 此外，心血管风险评分和 选定的抗高血压干预措施的生活质量指数 将被分析。 随访期平均约为5 年的体重减轻，通常的饮食比较，包括 TAIM随访，体重减轻2年-体重 损失/钠限制比较。