EFFECT OF VALSARTAN IN VENTRICULAR FUNCTION AND AORTIC ELASTICITY (CARDIAC)

这个子项目是众多研究子项目之一

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.