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感性测定，以建立原理证明。在第二阶段，我们提出了原型的评估，将定量测量我们的生物标志物在目标人群中。盐敏感性的理想生物标志物是与盐敏感性的根本原因而不是疾病症状相关的生物标志物。我们的假设是，该生物标志物可以使用基于单克隆抗体的直接定量ELISA准确测量。该检测将允许医生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。从这种准确的筛选试验中获得的信息将导致对盐敏感性及其病理生理后果（如高血压、CHF、肾脏疾病和水肿）的生物学机制的基础研究调查。我们请求II期支持，以便我们能够在关键研究中评估我们的原型盐敏感性试验，最终目标是获得FDA批准。此外，我们的提案还解决了几个研究问题，并探索了我们的检测在肾功能评估中令人兴奋的新的二次应用。 项目叙述 高血压影响着美国近5000万人，这使他们患慢性肾衰竭和心血管疾病的风险更高。在受影响的人中，约有一半是盐敏感的。我们将开发一种用于高血压患者的ELISA，可用于区分盐敏感和盐抵抗个体。

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.