A Test for Salt Sensitivity in People with Essential Hypertension

描述(由申请人提供)： 项目概述：在第一阶段，我们开发了一个模型系统和一个原型盐敏试验，以建立原则证明。在第二阶段，我们建议对原型进行评估，以定量测量我们在目标人群中的生物标记物。理想的盐敏感性生物标记物应该是与盐敏感性的根本原因有关的生物标记物，而不是疾病症状。我们的假设是，这个生物标记物可以使用基于单抗的直接定量ELISA法准确地测量。该测试将使医生能够识别新诊断的高血压患者的盐敏感性，以便尽早开始适当的治疗。从这一准确的筛查试验中获得的信息将导致对盐敏感的生物学机制及其病理生理后果(如高血压、充血性心力衰竭、肾脏疾病和水肿)的基础研究。我们请求第二阶段的支持，以便我们可以在一项关键研究中评估我们的原型盐敏试验，最终目标是获得FDA的批准。此外，我们的建议还解决了几个研究问题，并探索了我们的检测方法在评估肾功能方面令人兴奋的新的二次应用。 项目叙事 在美国，高血压影响着近5000万人，这使得他们患慢性肾功能衰竭和心血管疾病的风险更高。在受影响的人中，约有一半对盐敏感。我们将开发一种适用于高血压患者的ELISA，可以用来区分盐敏感和耐盐的个体。

DESCRIPTION (provided by applicant): Project Summary: In Phase I we developed a model system and a prototype Salt Sensitivity Assay to establish proof-of-principle . In Phase II we propose the evaluation of the prototype that will quantitatively measure our biomarker in the target population. An ideal biomarker for salt sensitivity would be one that is linked to the underlying cause of salt sensitivity and not disease symptoms. It is our hypothesis that this biomarker can be accurately measured using a monoclonal antibody-based direct quantitative ELISA. The assay will allow physicians to identify salt sensitivity in newly diagnosed hypertensive patients so that appropriate therapy can begin as early as possible. The information gained from this accurate screening test will lead to basic research investigations of the biological mechanisms underlying salt sensitivity and its pathophysiological consequences such as hypertension, CHF, renal disease, and edema. We request Phase II support so that we can evaluate our prototype Salt Sensitivity Assay in a pivotal study with the ultimate goal of obtaining FDA approval. In addition, our proposal also addresses several research questions and explores an exciting new secondary application of our assay in the assessment of renal function. Project Narrative Hypertension affects almost 50 million people in the United States, which places them at higher risk for chronic renal failure and cardiovascular disease. Of those affected, about half are salt-sensitive. We will develop an ELISA for hypertensive people that can be used to distinguish between salt sensitive and salt resistant individuals.