CLINICAL CENTERS FOR TRIALS OF HYPERTENSION PREVENTION

建议按以下亚组进行一系列随机试验： 与NHLBI合作协议的第一阶段的10个临床中心， 测试提供的可行性，并获得符合选定的 在人群中进行营养和行为非药物干预 正常高血压患者，并测量短期有效性 非药物干预减少或预防 DBP升高。 这一阶段是为了准备第二阶段的单一 涉及所有10个中心的随机对照试验， 优化的非药物干预方案可降低 明确的高血压（定义为持续DBP ≥ 90 mmHG 或由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后决定， 在第一阶段进行测试，第二阶段的最终单一最佳方案将是 由指导委员会。 在第一阶段，波士顿中心建议对3,000多名25岁的人进行筛查， 至49岁，以确定200名合格的未接受治疗的DBP参与者， 78-89，重量为理想重量的105-160%， 并且不受医疗或其他方面的限制。 在示例干预中， 由波士顿第一阶段研究中心提出， 基于美国心脏的卡路里限制修改 协会第二阶段饮食旨在减轻体重至少5%的身体 体重，将与定期剧烈运动的计划进行比较， 2 × 2析因设计：仅饮食，仅运动，饮食-运动， 两者都不是，以评估这些干预措施是否单独或联合使用 联合用药导致DBP显著降低， 控制 在第二阶段，波士顿中心计划筛选6000多名 确定有资格在II期随机分配的400名受试者 一项非药物干预的单一最佳方案试验， 降低高血压的发病率。 如果成功的话，这个项目将对公共卫生产生重大影响。 由于美国20%的成年人患有高血压， 与心脏病发作，中风， 过早死亡和其他疾病。

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.