TREATMENT OF MILD HYPERTENSION STUDY

这一建议是针对第一阶段，或"轻度高血压的治疗 研究"（TOMHS）。 轻度高血压（DBP 90 - 99 mmHg）的男性和女性， 年龄在45 - 69岁之间，药物治疗时DBP低于95 mmHg 并且没有与高血压相关的终末器官损伤的证据， 将被招募并随机分配到"I期"研究中。 随机化 将进行ut到四个可能的治疗条件之一：1） 安慰剂2）氯噻酮3）阿替洛尔4）哌唑嗪。 本研究是一项 双盲对照试验。 所有小组将同时给予 关于降低血压的非药物方法的建议 包括控制体重、减少饮食中的钠和减少饮酒 摄入 非药物干预将在第二次 资格审查（共3次）。 将至少进行门诊访视 每三个月和每年对所有参与者进行一次。 标准措施 将在基线和后续诊所访视以及 记录血压（随机-零）、体重、夜间尿钠， 钾和肌酐、血液化学、ECG、霍尔特监测仪，以及 超声心动图 四个临床中心将分别招募125名参与者。 这项研究将 由明尼苏达大学集中协调和管理， 公共卫生学院，流行病学和生物统计学系。 主要 I期终点为血压较基线的变化，II期终点为 是高血压相关的死亡率和发病率，包括以下证据： 终末器官损伤 第一阶段可行性研究包括六个月的规划，两个月的 招募后12个月的培训， 大约二十个月，六个月的分析和更新 准备，以及9个月过渡到研究的第二阶段。

This proposal is for Phase I, or, the "Treatment of Mild Hypertension Study" (TOMHS). Men and women with mild hypertension (DBP 90-99 mmHg) not on drugs, and DBP less than 95 mmHg on drugs, who are 45-69 years of age and free of evidence of end-organ damage related to their hypertension, will be recruited and randomized intothe "Phase I" study. Randomization will be carried ut to one of four possible treatment conditions: 1) placebo 2) chlorthalidone 3) atenolol 4) prazosin. The study is a double-blind controlled trial. All groups will be simultaneously given advice on non-pharmacologic methods designed to lower blood pressure including weigh control, dietary sodium reduction, and reduction of alcohol intake. The non-pharmacologic intervention will be initiated at the second eligibility visit (of three). Clinic visits will be conducted at a minimum of every three months and annually on all participants. Standard measures will be made at baseline and at subsequent clinic visits and at visits of record of blood pressure (random-zero), weight, overnight urine for sodium, potassium and creatinine, blood chemistries, ECG, Holter monitors, and echocardiograms. Four clinical centers will recruit 125 participants each. The study will be coordinated and administered centrally by the University of Minnesota, School of Public Health, Divisions of Epidemiology and Biometry. The major endpoint in Phase I is blood pressure change from baseline and for Phase II is hypertension related mortality and morbidity, including evidence of end-organ damage. The Phase I feasibility study inclues six months of planning, two months of training twelve months of recruitment, and average follow-up of approximately twenty months, six months of analysis and renewal preparation, and nine months for transition to Phase II of the study.