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Clinical Core

临床核心

基本信息

批准号：
9322488
负责人：
MARC A SIMON
金额：
$ 40.35万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9322488
关键词：
Address Animals Arteries Blood Blood Vessels Blood capillaries Blood specimen Cardiac Catheterization Procedures Categories Center for Translational Science Activities Chronic Chronic Obstructive Airway Disease Clinic Clinical Clinical Data Clinical Trials Collection Complex Conduct Clinical Trials Conjugated Linoleic Acids DNA Data Development Disease EFRAC Enrollment Etiology Fatty Acids Feces Fibroblasts Funding Goals HIV Infections Harvest Heart Diseases Heart failure Housing Human Hypoxemia Individual Industry Investigation Investigational Therapies Investments Left Link Lung Lung Transplantation Lung diseases Metabolic Metabolic syndrome Muscle Cells Nitrites Oral Outcome Pathogenesis Pathway interactions Patients Phase Phenotype Plasma Population Publications Pulmonary Hypertension Pulmonary artery structure RNA Recruitment Activity Registries Research Infrastructure Research Personnel Research Project Grants Resources Risk Risk Factors Role Sampling Smooth Muscle Subgroup Systemic disease Testing Therapeutic Therapeutic Intervention Time Translational trial Transplantation Treatment outcome United States National Institutes of Health Vascular Smooth Muscle Venous base biobank capillary clinical biomarkers clinical infrastructure dietary supplements hemodynamics improved insight microbiome novel therapeutic intervention novel therapeutics patient population patient registry personalized medicine pressure programs pulmonary arterial hypertension pulmonary artery endothelial cell response screening therapeutic target translational clinical trial treatment response treatment trial

项目摘要

Clinical Core Abstract The human core developed through the first 4 years has become an established center for translational research in pulmonary hypertension (PH), encompassing a large biorepository and clinical trials coordinating center. The goal of the human core during this renewal is to support all Research Projects by 1) providing the infrastructure and expertise necessary to conduct clinical trials of new therapies of dietary supplements for Group I and Group II PH, and 2) collecting hemodynamic, clinical, biomarker, and microbiome data on PH patients for robust phenotyping. Specific expansions of the human core for this renewal include enrollment of Groups I-V PH patients into the human subphenotyping core registry to provide mechanistic insight into endo- phenotypes of PH including the role of the microbiome in PH, collection of pulmonary artery endothelial cells during clinical right heart catheterization, as well as harvest of isolated endothelial, smooth muscle and lung fibroblasts from human lungs of PH patients removed at time of transplantation. The core will draw on the extensive clinical and research infrastructure harnessed during the first phase of the TPPG including 14 clinics, over 1,000 clinical right heart catheterization each year, 34 ongoing NIH- or industry-funded research projects, over 2,500 biospecimens banked, a vascular clinical translational research center specializing in assessment of endothelial function for 9 NIH- or industry-funded research projects, and over 1,200 patients enrolled in clinical trials over the past five years. The human core is critical to all Projects to fulfill the translational directive of the TPPG, in which each Project will conduct a clinical or translational trial. This unmatched resource will accelerate the pace of discovery in the Projects by rapidly identifying appropriate patients for clinical trials and by providing a wealth of biospecimens with corresponding clinical data for mechanistic investigations.

临床核心摘要通过前4年发展的人力核心已经成为一个既定的翻译中心，肺动脉高压（PH）研究，包括大型生物储存库和临床试验，中心在此更新期间，人力核心的目标是通过以下方式支持所有研究项目：1）提供进行膳食补充剂新疗法临床试验所需的基础设施和专业知识，第I组和第II组PH，以及2）收集PH的血流动力学、临床、生物标志物和微生物组数据患者进行稳健的表型分析。此次更新的人力核心的具体扩展包括招募将I-V PH患者分组到人类亚表型核心登记处，以提供对内分泌的机制性见解。 PH的表型，包括微生物组在PH中的作用，肺动脉内皮细胞的收集在临床右心导管插入术以及分离的内皮、平滑肌和肺的收获期间来自在移植时取出的PH患者的人肺的成纤维细胞。核心将利用在TPPG第一阶段利用了广泛的临床和研究基础设施，包括14个诊所，每年有超过1,000例临床右心导管插入术，34个正在进行的NIH或行业资助的研究项目，超过2，500个生物样本库，一个血管临床转化研究中心，专门从事评估 9个NIH或行业资助的研究项目的内皮功能，超过1,200名患者参加了在过去五年的临床试验中。以人为本是所有项目实现翻译指令的关键每个项目将进行临床或转化试验。这一无与伦比的资源将通过快速识别适合进行临床试验的患者，加快项目发现的步伐，通过提供大量的生物样本和相应的临床数据进行机理研究。