Clinical Core

临床核心摘要 经过前4年的发展，人类核心已经成为翻译的既定中心 对肺动脉高压(PH)的研究，包括大型生物信息库和临床试验的协调 中间。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 第一组和第二组PH，以及2)收集关于PH的血流动力学、临床、生物标记物和微生物组数据 患者需要稳健的表型鉴定。此次续签的人力核心的具体扩展包括注册 将I-V PH患者分组到人类亚表型核心注册表，以提供对内毒素的机械性洞察。 PH的表型，包括微生物群在PH中的作用，收集肺动脉内皮细胞 在临床右心导管术中，采集分离的内皮、平滑肌和肺 移植时取自人肺的肺成纤维细胞。核心层将利用 在TPPG的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， 每年超过1000例临床右心导管术，34个正在进行的NIH或行业资助的研究项目， 超过2500个生物标本银行，一个专门从事评估的血管临床翻译研究中心 9个NIH或行业资助的研究项目的内皮功能，以及超过1200名患者参加了 过去五年的临床试验。人的核心对于实现翻译指令的所有项目都至关重要 每个项目将进行一项临床或转化性试验。这一无与伦比的资源将 通过快速确定合适的患者进行临床试验和 通过为机制研究提供丰富的生物标本和相应的临床数据。

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.