ANTIHYPERTENSIVE AND LIPID LOWERING TREATMENT TO PREVENT HEART ATTACK

抗高血压和降脂治疗预防心脏病

• 批准号: 6304984
• 负责人: GEORGE W. VETROVEC
• 金额: $ 0.06万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304984
• 关键词: ACE inhibitors; alpha adrenergic agent; antihypertensive agents; calcium channel blockers; cardiovascular disorder prevention; clinical research; clinical trials; coronary disorder; diuretics; heart disorder chemotherapy; human mortality; human subject; human therapy evaluation; lipogenesis inhibitor; myocardial infarction; outcomes research

A determination of effectiveness of three new blood pressure-lowering drugs; lisinopril, amlodipine, and doxazocin as compared to the standard forms of treatment with diuretic drugs. An estimated 50 million people in the United States have elevated blood pressure or are taking medications for high blood pressure. There is known relationship between high blood pressure and coronary heart disease (CHD), but large-scale, randomized clinical trials in mild to moderately high blood pressure in largely middle-aged subjects failed to show that high blood pressure drug treatment reduces the occurrence of cardiac disease death or non-fatal myocardial infarction (the death of heart tissue due to lack of blood supply to the area). The primary hypothesis of this trial is that the combined incidence of fatal heart disease and non-fatal myocardial infarction will be lower in patients with high blood pressure who receive the three medications. The study will involve a population of men and women 55 years and older, all with at least one additional CHD risk factor besides high blood pressure, 55% of whom will be African-American, a race more prone to high blood pressure. There will be a trial component to lower blood pressure and a trial component to lower cholesterol. Study drugs will be randomly assigned. Patients will be seen at four week intervals until a reasonably stable regimen with satisfactory blood pressure control has been achieved. Clinic visits will then take place every three months during the first year and every four months thereafter. Blood pressure will be taken at each visit. An electrocardiogram test will be given at visit two. Potassium levels will be checked at one month, one year, two years, four years, and at six years. Blood tests will be done as well as tests for creatinine serum., fasting cholesterol, and serum glucose. At every visit, a determination of compliance with study medications will be done. Quality of life will be discussed at the entry of the study and every year thereafter.

三种新型降压药的疗效测定赖诺普利、氨氯地平和多沙唑星与标准利尿剂治疗形式的比较。据估计，美国有5000万人患有高血压或正在服用治疗高血压的药物。高血压与冠心病（CHD）之间的关系是已知的，但在以中年人为主的轻度至中度高血压患者中进行的大规模随机临床试验未能显示高血压药物治疗可降低心脏病死亡或非致死性心肌梗死（由于该区域血液供应不足而导致心脏组织死亡）的发生。本试验的主要假设是，接受这三种药物治疗的高血压患者的致死性心脏病和非致死性心肌梗死的总发病率将降低。这项研究将涉及55岁及以上的男性和女性人群，除了高血压之外，他们都至少有一个额外的冠心病风险因素，其中55%将是非裔美国人，一个更容易患高血压的种族。会有降低血压和降低胆固醇的试验。研究药物将随机分配。患者将每四周观察一次，直到达到相当稳定的血压控制方案为止。第一年将每三个月进行一次门诊检查，此后每四个月进行一次门诊检查。每次就诊都会测量血压。在第二次就诊时进行心电图检查。钾水平将在1个月、1年、2年、4年和6年进行检查。血液检查和血清肌酐检查都要做。空腹胆固醇和血清葡萄糖。在每次访问时，将确定对研究药物的依从性。生活质量将在研究开始时以及之后的每一年进行讨论。