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A Test for Salt Sensitivity in People with Essential Hypertension

原发性高血压患者的盐敏感性测试

基本信息

批准号：
7395153
负责人：
STEPHEN L CARRITHERS
金额：
$ 50.41万
依托单位：
SEQUELA
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-04-01 至 2010-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7395153
关键词：
Acute Address Adult Affect Affinity Animal Model Animals Archives Award Basic Science Biochemical Biological Biological Assay Biological Markers Biological Models Blood Blood Pressure Bolus Infusion Cardiovascular Diseases Chronic Kidney Failure Clinical Research Clinical Trials Collaborations Condition Development Diabetes Mellitus Diagnostic Disease Edema End stage renal failure Endocrine Endocrinology Enteral Enzyme-Linked Immunosorbent Assay Essential Hypertension Evaluation Excretory function Funding Goals Heart Hematological Disease Homeostasis Hour Human Hypertension Individual Infusion procedures Institutes Intake Intestines Investigation Kidney Kidney Diseases Knock-out Laboratories Lead Letters Link Lung Maine Marketing Measures Messenger RNA Monoclonal Antibodies Mus NIH Program Announcements National Institute of Diabetes and Digestive and Kidney Diseases Natriuretic Peptides Newly Diagnosed Oral Participant Patients Peptides Personal Satisfaction Phase Physicians Physiological Plasma Play Preparation Principal Investigator Protocols documentation Radioimmunoassay Rattus Reagent Regulation Renal function Reporting Request for Applications Research Research Ethics Committees Research Personnel Resistance Risk Rodent Model Role Sampling Screening procedure Series Small Business Funding Mechanisms Small Business Innovation Research Grant Sodium Sodium Chloride Sodium-Restricted Diet Staging Stomach Symptoms Target Populations Testing United States United States Food and Drug Administration United States National Institutes of Health Urine Work base guanylin human study medical schools mouse model normotensive polyclonal antibody programs prohormone prototype research study response salt intake salt sensitive scale up uroguanylin urologic validation studies

项目摘要

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.

描述（由申请人提供）：项目摘要：在第一阶段，我们开发了一个模型系统和盐敏感性测定原型，以建立原理验证。在第二阶段，我们建议对原型进行评估，该原型将定量测量目标人群中的生物标志物。盐敏感性的理想生物标志物应该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。我们假设可以使用基于单克隆抗体的直接定量 ELISA 准确测量该生物标志物。该测定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。从这项准确的筛查测试中获得的信息将有助于对盐敏感性的生物学机制及其病理生理学后果（如高血压、CHF、肾脏疾病和水肿）进行基础研究。我们请求 II 期支持，以便我们可以在一项关键研究中评估我们的原型盐敏感性测定，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，并探索了我们的测定在肾功能评估中令人兴奋的新的二次应用。项目叙述在美国，高血压影响着近 5000 万人，这使得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，大约一半对盐敏感。我们将为高血压患者开发一种 ELISA，可用于区分盐敏感个体和耐盐个体。