LOSARTAN INTERVENTION FOR ENDPOINT REDUCTION (LIFE)

LIFE试验的假设是（主动招募阶段已完成-仅患者随访仍在继续），与阿替洛尔相比，氯沙坦将使原发性高血压和左心室肥大（LVH）患者的心血管（CV）发病率和死亡率降低15%。 主要终点是CV发病率和死亡率的合并发生率。 主要目的是评估长期影响氯沙坦（+/>4年）与阿替洛尔相比，在有记录的LVH的高血压患者中对CV发病率和死亡率的联合影响（CV死亡率定义为致死性心肌梗死[MI]、致死性卒中、猝死、进展性心力衰竭导致的死亡和其他CV死亡; CV发病率定义为非致死性MI [不包括无症状MI]和非致死性卒中）。 LIFE研究包括以下子研究：生活质量（子研究ID编号133-03）--该子研究的目的是评估在治疗1、2、6和12个月时接受氯沙坦与阿替洛尔治疗的高血压伴LVH患者的生活质量差异。 该子研究检查了治疗相关影响，定义为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域）和与疲倦/疲乏相关的症状量表项目的反应。 这些反应记录在自我管理的同类质量（QoL）问卷中，该问卷专为高血压临床研究设计。 该问卷是一组量表，使用现有的经验证的QoL工具组。非洲裔美国人LIFE试验的超声子研究（子研究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子研究。 将在美国对大约360名非洲裔美国人进行随访（美国患者总数的目标是3,000名）。 通过ECG（Cornell标准）确定是否存在LVH是主要LIFE试验的主要入选标准，通过ECG确定LVH消退的比较被列为研究目的。然而，一些研究已经证明，在黑人中通过ECG评估LVH的准确性明显低于其他种族人群。 在黑人和白色人群中，超声心动图对LVH的诊断相似。 LIFE试验使用了一种据称更准确的康奈尔标准（QRS电压持续时间乘积）来评估LVH;然而，这种方法尚未在大量黑人高血压患者中得到充分评价。 这显然会在将LIFE试验的结果外推到主要高血压人群时产生问题。ECG在黑人与白色人群中识别LVH的准确性差异的原因尚不清楚，由于LVH风险的准确评估对试验至关重要，因此LIFE试验必须使用最佳方法确定所有人群中是否存在LVH。 因此，LIFE包括一项超声心动图子研究，以确定LIFE试验ECG标准和其他方法与超声心动图诊断的LVH的相关性。 如果达到美国研究人群10-15%（约360名）的预期组成，并且将该人口统计学特征纳入“LIFE试验超声心动图子研究”样本中，则将仅研究35-50名黑人受试者。 这不足以验证整个研究中黑人的ECG结果。 因此，“LIFE试验的美国黑人超声子研究”在LIFE试验和超声心动图子研究中对黑人进行了过采样;将使用LIFE试验ECG标准和超声心动图对该队列进行随访，以确认LIFE试验结果在黑人高血压患者中的有效性。具体来说，将评估LIFE试验心电图标准在检测试验黑人参与者中超声心动图证实的LVH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.