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

缬沙坦对心室功能和主动脉弹性（心脏）的影响

• 批准号: 7606920
• 负责人: ARISTIDIS VEVES
• 金额: $ 0.53万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606920
• 关键词: Angiotensin II; Blood Vessels; Cardiac; Cardiac Output; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Diabetes Mellitus; Double-Blind Method; Elasticity; End Point; Evaluable Disease; Funding; Grant; Heart; Institution; Left; Magnetic Resonance Imaging; Measurement; Measures; Outpatients; Patients; Phase; Physiologic pulse; Placebo Control; Placebos; Population; Population Analysis; Pulse taking; Purpose; Randomized; Research; Research Personnel; Resources; Right ventricular structure; Safety; Source; Stroke Volume; United States National Institutes of Health; Ventricular Function; Week; indexing; receptor; treatment duration; valsartan

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这是IV期，随机，双盲，安慰剂对照的跨界临床试验。该试验的主要目的是检查血管紧张素II（1时）受体拮抗剂（Valsartan）对糖尿病和健康对照患者心室功能和主动脉弹性的影响。这项研究将是门诊，最后14个月。在接下来的6个月中，大约30名受试者（每组中有15名）将随机分为安慰剂或瓦尔萨坦（Valsartan）或前6个月。为期8周的冲洗期将分开两个治疗期。心室功能和主动脉弹性将使用心脏的MRI测量。心脏功能（EF），左心室和右心室的主要功效终点。主要的血管弹性测量将是动脉依从性，刚度指数和脉搏波速度。疗效分析的主要人口将是完成这项研究的人群。为了安全起见，所有进入研究的受试者均可评估。