BOSENTAN VS PLACEBO IN NYHA CLASS I/II SCLERODERMA PATIENTS WITH EXERCISE INDUCE

波生坦与安慰剂在 NYHA I/II 级硬皮病患者运动诱导中的比较

• 批准号: 7951985
• 负责人: VIRGINIA D STEEN
• 金额: $ 0.35万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951985
• 关键词: Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Development; Diagnosis; Disease Progression; Doppler Echocardiography; Early identification; Echocardiography; Endothelin-1; Exercise; Exercise stress test; Funding; Grant; Institution; Lead; Lung; Lung diseases; Patients; Pharmaceutical Preparations; Placebos; Pulmonary Hypertension; Pulmonary artery structure; Recruitment Activity; Research; Research Personnel; Resources; Rest; Risk; Scleroderma; Source; Stress; Stress Echocardiography; Systemic Scleroderma; Systolic Pressure; Testing; United States National Institutes of Health; Vascular Diseases; Walking; bosentan; improved; pressure

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Pulmonary hypertension (PAH) is a common and usually fatal form of lung disease in systemic sclerosis (SSc). Multiple drugs have been approved for the treatment of Class III/IV PAH in scleroderma. Bosentan is an endothelin-1 antagonist which showed significant improvement in distance walked during 12 week clinical trials in PAH patients (7). Therapy for asymptomatic systemic sclerosis patients diagnosed incidentally with PAH (WHO Functional Class I) remains controversial. We hypothesize that asymptomatic or minimally symptomatic patients with systemic sclerosis and normal resting pulmonary artery pressures who demonstrate an abnormal rise in pulmonary artery systolic pressure with stress Doppler echocardiography testing represent a subset of patients who already have pulmonary vascular disease and who are at risk for the development of severe PAH. We further hypothesize that early identification and treatment of such patients may retard the progression of that disease. Hypotheses: 1. Stress echocardiography identifies early pulmonary vascular disease by detecting exercise-induced pulmonary hypertension in patients with systemic sclerosis. 2. Treatment of exercise-induced PAH with Bosentan will lead to improved exercise endurance in patients with systemic sclerosis. Subjects will be recruited from those patients who have had an abnormal exercise test as part of an earlier study, Exercise Echocardiograms in Scleroderma (IRB# 03-363).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 肺高血压（PAH）是全身性硬化症（SSC）中肺部疾病的常见且通常是致命的形式。 多种药物已被批准用于在硬皮病中的III/IV类PAH治疗。波森坦是一种内皮蛋白-1拮抗剂，在PAH患者的12周临床试验中行走的距离显着改善（7）。无症状的全身性硬化症患者偶然被PAH诊断（WHO功能I类）的治疗仍然有争议。我们假设无症状或微小症状性患有全身性硬化症和正常静静脉肺动脉压力的患者表现出异常的肺动脉收缩压升高，并具有压力多普勒超声心动图检测，这些患者代表已经患有肺血管疾病的患者的子集，并且患有严重PAH的风险。我们进一步假设，早期鉴定和治疗此类患者可能会阻碍该疾病的进展。 假设： 1。应力超声心动图通过检测系统性硬化症患者的运动诱导的肺动脉高压来鉴定早期肺血管疾病。 2。用波森坦治疗运动诱导的PAH将导致全身性硬化症患者的运动耐力改善。作为早期研究的一部分，在硬皮病中运动超声心动图（IRB＃03-363）的运动超声心动图的一部分的患者（IRB＃03-363），将招募受试者。