LOSARTAN INTERVENTION FOR ENDPOINT REDUCTION (LIFE)

生命试验的假设是(主动登记阶段已经完成--只有患者的随访仍在继续)，与阿替洛尔相比，洛沙坦将使患有高血压和左心室肥厚(LVH)的患者的心血管(CV)发病率和死亡率降低15%。主要终点是心血管发病率和死亡率的综合发生率。该研究的主要目标是评估在高血压患者中服用氯沙坦和阿替洛尔在心血管发病率和死亡率方面的长期效果(+/&gt；4年)。LIFE研究包括以下子研究：生活质量(子研究ID：133-03)--这项子研究的目的是评估在治疗1、2、6和12个月后接受氯沙坦和阿替洛尔治疗的高血压和左心室肥厚患者的生活质量的差异。这项分研究考察了治疗相关的影响，如患者对健康相关领域(心理健康)活力评分(心理健康下的一个子领域)和与疲劳/疲劳有关的症状清单项目的反应所定义的。这些回答被记录在自我管理的相似质量(QOL)问卷上，该问卷是专门为高血压临床研究设计的。这份问卷是一组量表，利用了现有的、经过验证的生活质量量表。非洲裔美国人ECHO-LIFE试验的亚研究(亚研究ID编号133-05)--LIFE试验将在每个国家12%的研究人群中进行超声心动图亚研究。大约360名非裔美国人将在美国接受跟踪调查(美国患者总数的目标是3000人)。心电图室壁肥厚(康奈尔标准)是主要寿命试验的主要纳入标准，比较心电图室壁肥厚的回归被列为研究目标。然而，一些研究已经证明，在黑人中，通过心电来评估左心室肥厚的准确性明显低于其他种族人群。在黑人和白人人群中，超声心动图诊断的左心室肥厚是相似的。生命试验使用了康奈尔标准(QRS电压持续时间乘积)的更准确的修改来评估LVH；然而，这种方法还没有在大量的黑人高血压患者中得到充分的评估。这显然会在将生命试验的结果外推到高血压患者的主要人群方面产生问题。在黑人和白人人群中，心电图识别LVH的准确性差异的原因尚不清楚，由于准确评估LVH风险对于试验至关重要，因此对于生命试验来说，利用最佳方法确定所有人群中是否存在LVH至关重要。因此，LIFE包括一项超声心动图的子研究，通过生命试验的心电图标准和其他方法来确定LVH与超声心动图诊断的LVH的相关性。如果美国研究人群的预期构成达到了10-15%(约360)的非裔美国人，并且这一人口统计学特征被带入“生命试验超声心动图分研究”样本，那么只有35-50名黑人受试者将被研究。这是一个不足以在完整研究中验证黑人的心电图结果的黑人人数。因此，在生命试验和超声心动图亚研究中，“非裔美国人回声-生命试验亚研究”对黑人进行了过度抽样；这一队列将同时使用生命试验心电图标准和超声心动图，以确认黑人高血压患者生命试验结果的有效性。具体地说，将评估生命试验心电标准在检测试验中经超声心动图证实的黑人受试者左室肥厚方面的特异性。

The hypothesis of the LIFE trial is (active enrollment phase is completed--only patient followup is continuing) that, compared to atenolol, losartan will reduce the incidence of cardiovascular (CV) morbidity and mortality in patients with essential hypertension and left ventricular hypertrophy (LVH) by 15%. The primary endpoint is the combined incidence of CV morbidity and mortality. The primary objective is to evaluate the long-term effects (+/>4 years) of losartan compared to atenolol in hypertensive patients with documented LVH on the combination of CV morbidity and mortality (CV mortality defined as death due to fatal myocardial infarction [MI], fatal stroke, sudden death, death resulting from progressive heart failure and other CV deaths; CV morbidity defined as nonfatal MI [excluding silent MI]and nonfatal stroke). The LIFE Study includes the following substudies: QUALITY OF LIFE (Substudy ID No. 133-03)--The purpose of this substudy is to assess differences in quality of life among patients with hypertension and LVH who are treated with losartan versus atenolol at 1, 2, 6 and 12 months of therapy. This substudy examines the treatment-related influences, as defined by patient responses on the health-related domain (psychological well-being) score for vitality ( a subdomain under psychological well-being) and the symptom inventory item relating to tiredness/fatigue. These responses are recorded on a self-administered quality of like (QoL) questionnaire which has been specifically designed for hypertensive clinical studies. This questionnaire is a battery of scales utilizing groups of existing, validated QoL instruments. AFRICAN AMERICAN ECHO-SUBSTUDY FOR LIFE TRIAL (Substudy ID No. 133-05)--The LIFE trial is to conduct an echocardiographic substudy in 12% of the study population in each country. Approximately 360 African Americans will be followed in the U.S. (goal for total U.S. patients is 3,000). The presence of LVH by ECG (Cornell criteria) is a major inclusion criteria for the main LIFE trial, and the comparison of LVH regression by ECG is listed as a study objective. However, several studies have documented that the assessment of LVH by ECG in Blacks is significantly less accurate than in other ethnic populations. The diagnosis of LVH by echocardiogram was similar in Black and White populations. The LIFE trial uses a supposedly more accurate modification of the Cornell criteria (QRS voltage duration product) for LVH assessment; however, this method has not been adequately evaluated in significant numbers of Black hypertensives. This will clearly create problems in extrapolating the results of the LIFE trial to a major population of hypertensives. The reasons for the difference in accuracy of the ECG in identifying LVH in Black vs White populations are unknown and, since the accurate assessment of LVH risk is essential for the Trial, it is essential for the LIFE trial that it is utilizing the best method for determining the presence of LVH in all populations. Thus, LIFE included an echocardiographic substudy to determine the correlation of LVH by the LIFE Trial ECG criteria and other methods with echocardiographically diagnosed LVH. If the desired composition of the U.S. study population of 10-15% (~360) African Americans is achieved and this demographic profile is carried over into the "LIFE Trial Echocardiographic Substudy" sample, only 35-50 Black subjects will be studied. This is an insufficient number of Blacks to validate the ECG findings in Blacks in the full study. Thus, the "AFRICAN AMERICAN Echo-Substudy for the LIFE Trial" oversampled Blacks in the LIFE Trial and Echocardiographic Substudy; this cohort will be followed using both the LIFE Trial ECG criteria and echocardiography to confirm the validity of the LIFE Trial results in Black hypertensives. Specifically, the specificity of the LIFE Trial ECG criteria in the detection of echocardiographically confirmed LVH in the Trial's Black participants will be assessed.