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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者的研究机构。 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（AT 1）受体拮抗剂（缬沙坦）对糖尿病患者和健康对照者心功能和主动脉弹性的影响。研究将在门诊进行，持续14个月。约30例受试者（每组15例）将随机分配至安慰剂组或缬沙坦组或前6个月，并在随后6个月接受相反治疗。8周洗脱期将分隔两个治疗期。将使用心脏MRI测量心室功能和主动脉弹性。主要疗效终点为左心室和右心室的心功能（EF）、每搏输出量和心输出量。血管弹性的测量主要是动脉顺应性、僵硬度指数和脉搏波速度。疗效分析的主要人群将是完成研究的人群。对于安全性，所有入组研究的受试者都将可评价。

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.