CLINICAL TRIAL: EFFECT OF VALSARTAN IN VENTRICULAR FUNCTION AND AORTIC ELASTICIT

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项IV期随机、双盲、安慰剂对照、交叉临床试验。本试验的主要目的是观察血管紧张素II(AT1)受体拮抗剂(Valsartan)对糖尿病患者和健康对照组的心功能和主动脉弹性的影响。这项研究将在门诊进行，持续14个月。大约30名受试者(每组15名)将被随机分配到安慰剂或valsartan组或前6个月，并在接下来的6个月接受相反的治疗。为期8周的洗涤期将把两个治疗期分开。心功能和主动脉弹性将使用心脏的核磁共振进行测量。主要疗效终点为左、右室心功能(EF)、每搏输出量和心输出量。主要的血管弹性测量将是动脉顺应性、僵硬指数和脉搏波速度。疗效分析的主要人群将是完成研究的人群。为了安全起见，所有进入研究的受试者都将是可评估的。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase IV, randomized, double-blinded, placebo-controlled, crossover clinical trial. The main purpose of this trial is to examine the effects of angiotensin II (AT 1) receptor antagonist (valsartan) on the ventricular function and aortic elasticity of patients with diabetes mellitus and healthy controls. The study will be out-patient and last 14 months. Approximately 30 subjects (15 in each group) will be randomized to either placebo or valsartan or the first 6 months and to the opposite treatment the next 6 months. An 8-week washout period will separate the two treatment periods. Ventricular function and aortic elasticity will be measured using the MRI of the heart. The primary efficacy endpoints for the cardiac function (EF), stroke volume and cardiac output of the left and the right ventricles. The main vascular elasticity measurement will be the arterial compliance, stiffness index and pulse wave velocity. The primary population for the analysis for efficacy will be the population who completed the study. For safety, all subjects who enter the study will be evaluable.