TREATMENT OF MILD HYPERTENSION STUDY

轻度高血压的治疗研究

• 批准号: 3348071
• 负责人: Richard Hugo Grimm
• 金额: $ 249.85万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-09-30 至 1990-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3348071
• 关键词: alcoholic beverage consumption; antihypertensive agents; arrhythmia; atenolol; beta antiadrenergic agent; cardiovascular disorder chemotherapy; cardiovascular disorder diagnosis; cardiovascular disorder prevention; clinical chemistry; dietary mineral; diuretics; drug adverse effect; electrocardiography; human middle age (35-64); human subject; hypertension; longitudinal human study; medical complication; nifedipine; nutrition related tag; prazosin; weight control

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.

这项提案针对的是第一阶段，也就是“治疗轻度高血压” 研究“(TOMHS)。患有轻度高血压(DBP 90-99毫米汞)的男性和女性没有 服药，服药舒张压低于95毫米汞柱，年龄45-69岁 而且没有与高血压有关的终末器官损伤的证据， 将被招募并随机进入“第一阶段”研究。随机化 将被带到四种可能的治疗条件之一：1) 安慰剂氯泰利酮、阿替洛尔、哌唑嗪。该研究是一项 双盲对照试验。所有小组将同时获得 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酒精 入口处。非药物干预将在第二天启动 资格访问(共三个)。诊所就诊将至少进行 每三个月和每年对所有参与者进行一次审查。标准衡量标准 将在基线、随后的诊所就诊和 记录血压(随机为零)、体重、夜间尿钠、 钾和肌酐，血液化学，心电图，动态心电图仪，和 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。少校 第一阶段的终点是基线和第二阶段的血压变化 高血压是否与死亡率和发病率有关，包括证据 末梢器官损伤。 第一阶段可行性研究包括六个月的规划、两个月的 培训12个月的招聘，平均随访 大约20个月、6个月的分析和更新 准备工作，9个月过渡到研究的第二阶段。