TRIAL OF NONPHARMACOLOGIC INTERVENTIONS IN THE ELDERLY

老年人非药物干预试验

• 批准号: 2224713
• 负责人: JOHN B KOSTIS
• 金额: $ 62.13万
• 依托单位: UNIV OF MED/DENT NJ-R W JOHNSON MED SCH
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-04-01 至 1996-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2224713
• 关键词: antihypertensive agents; behavior modification; blood chemistry; blood pressure; body physical activity; body weight; caloric dietary content; cardiovascular disorder; clinical trials; diet therapy; gender difference; human old age (65+); human subject; human therapy evaluation; hypertension; interview; low salt diet; nutrition education; nutrition of aging; nutrition related tag; obesity; quality of life; questionnaires; racial /ethnic difference; reducing diet; statistics /biometry; urinalysis; weight loss

A substantial proportion (probably 30-40%) of elderly persons are being treated with BP medications. The efficacy of BP drug therapy in older patients with diastolic or combined diastolic/systolic hypertension is well proven but there is little doubt that such therapy can adversely effect quality of life and biochemical profile. there is a compelling rationale to (1) identify what proportion of medicated, well-controlled elderly hypertensives can be maintained (long-term; > 30 months) in the normotensive state following withdrawal of BP medications, and (2) determine whether non-pharmacologic therapy can significantly increase the proportion with a successful outcome. Nine-hundred subjects (225 in each of four centers) 65-80 yrs. with a SBP < 160 and DBP < 90 mmHg while receiving one BP medication will be enrolled in a trial to test the efficacy of weight loss and sodium restriction (alone and combined) in maintaining the normotensive state following withdrawal of antihypertensive medications. Six-hundred overweight participants will be randomly assigned to weight loss, sodium restriction, combined weight loss and sodium restriction, or attention control. Three- hundred non-overweight participants will be randomly assigned to a sodium restriction or attention control group. The attention groups will be engaged in a series of non-BP related health encounters designed to control for non-specific effects of groups contacts. Withdrawal of antihypertensive medications will be attempted following 6 weeks of intervention. the primary trial endpoint will be need for recurrent antihypertensive drug therapy. The significance of the proposed study is that our findings may identify a non-pharmacologic approach which provides a safe and well-tolerated method by which to discontinue antihypertensive drug therapy in the approximately 15 million persons > 65 years who are currently being treated with BP medications. In addition, our study will identify the proportion of elderly hypertensives who can be maintained in the normotensive state without any intervention following withdrawal of their BP medications.

相当大比例(可能是30%-40%)的老年人 用英国石油公司的药物治疗。老年患者BP药物治疗的疗效观察 舒张期或合并舒张期/收缩期高血压的患者情况良好 已得到证实，但毫无疑问，这种疗法会产生负面影响 生活质量和生化指标。有一个令人信服的理由 为了(1)确定服用药物、控制良好的老年人所占比例 高血压患者可以长期维持(30个月)。 停用血压药物后血压正常状态，以及(2) 确定非药物治疗是否能显著增加 比例与成功的结果。 900名受试者(四个中心各225名)年龄在65-80岁之间。使用SBP 在接受一次BP药物治疗的同时，将参加160和DBP&lt；90 mm Hg的治疗 在一项测试减肥和限钠效果的试验中 (单独和联合)维持正常血压状态 停用抗高血压药物。超重六百 参与者将被随机分配到减肥，限制钠， 减肥和钠限制相结合，或控制注意力。三个- 100名非超重的参与者将被随机分配到一种钠 限制或注意对照组。关注小组将是 参与了一系列与BP无关的健康会面，旨在控制 对于群体接触的非特定影响。撤回 6周后将尝试服用降压药 干预。循环试验将需要主要试验终点 抗高血压药物治疗。拟议研究的意义在于 我们的发现可能会确定一种非药理学方法，它提供了 一种安全、耐受性好的停用抗高血压药物的方法 约1500万65岁以上老年人的药物治疗 目前正在接受BP药物治疗。此外，我们的研究将 确定可以维持的老年高血压患者的比例 停药后无任何干预的正常血压状态 他们的降压药。