CLINICAL CENTERS FOR TRIALS OF HYPERTENSION PREVENTION

一系列随机试验建议由以下几个小组进行 与NHLBI达成合作协议第一阶段的十个临床中心 测试提供并获得所选内容的合规性的可行性 人群中的营养和行为非药物干预 正常血压偏高者，并衡量近期疗效 非药物干预措施在减少或预防 舒张压上升。这一阶段是为第二阶段单曲做准备 涉及所有10个中心的随机对照试验，以测试单个 最佳的非药物干预方案可降低发病率 明确的高血压(定义为持续舒张压大于或等于90毫米汞柱 或个人开始使用抗高血压药物治疗 医生)。关于各种具体干预措施的最终决定将是 在第一阶段进行测试，第二阶段的最终单一最优方案将是 由指导委员会提出。 在第一阶段，波士顿中心建议对3000多名25岁的人进行筛查 到49年，以确定200名符合条件的参与者未经治疗的DBP 78-89在三级屏幕上，重量从理想重量的105%-160%， 并且没有医疗或其他方面的排除。在示例干预中 由波士顿第一阶段中心提出，这是一个多因素饮食计划 基于对美国心脏的卡路里限制改造 协会第二阶段饮食旨在减轻身体至少5%的体重 体重，将与使用常规剧烈运动的计划进行比较 2x2析因设计：仅限饮食、仅限锻炼、节食-锻炼 都不是，评估这些干预措施是单独进行还是在 联合应用可显著降低舒张压 控制力。在第二阶段，波士顿中心计划筛查6000多人 识别400名有资格在第二阶段随机编配的人士 一种单一最佳非药物干预方案的试验 降低高血压的发病率。 如果成功，这项计划可能会对公共卫生产生重大影响 由于美国20%的成年人口患有高血压，这是 与心脏病发作、中风的风险显著增加有关， 过早死亡和其他发病率。

A series of randomized trials is proposed to be conducted by subgroups of ten clinical centers in Phase I of a cooperative agreement with NHLBI to test the feasibility of providing, and obtaining compliance with selected nutritional and behavioral non-pharmacologic interventions in a population with high normal blood pressure and to measure the short term effectiveness of the non-pharmacologic interventions on reducing or preventing an increase in DBP. This phase is done in preparation for a Phase II single randomized control trial involving all ten centers to test whether a single optimal regimen of non-pharmacologic intervention can reduce the incidence of definite hypertension (defined as a sustained DBP of 90mmHG or greater or the initiation of treatment with antihypertensive drugs by a personal physician). Final decision on the various specific interventions to be tested in Phase I and the final single optimal regimen in Phase II will be made by the Steering Committee. In Phase I, the Boston center proposes to screen over 3,000 persons aged 25 to 49 years to identify 200 eligible participants with untreated DBP from 78-89 on a three stage screen, with weights from 105-160% of ideal weight, and free of medical or other exclusions. In the example interventions posed by the Boston center for Phase I, a multifactorial dietary program based on a calorie restricted modification of the American Heart Association Phase II diet aimed at weight reduction of at least 5% of body weight, will be compared with a program of regular vigorous exercise using a 2x2 factorial design: diet only, exercise only, diet-exercise, and neither, to assess whether either of these interventions alone or in combination result in a significant lowering of DBP as compared to control. In Phase II, the Boston center proposes to screen over 6,000 persons to identify 400 persons eligible to be randomized in the Phase II trial of a single optimal regimen of non-pharmacologic intervention to reduce the incidence of hypertension. If successful, this program could be of great public health significance since 20% of the adult population in the U.S. has hypertension which is associated with significantly elevated risk of heart attack, stroke, premature death and other morbidity.