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).

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 在系统性硬化症(SSC)中，肺动脉高压(PAH)是一种常见且通常是致命的肺部疾病。 多种药物已被批准用于治疗硬皮病的III/IV类PAH。波生坦是一种内皮素-1拮抗剂，在12周的临床试验中，它在PAH患者的步行距离方面有显著改善[7]。对偶然诊断为PAH(WHO Function Class I)的无症状系统性硬化症患者的治疗仍存在争议。我们假设，无症状或无症状的系统性硬化症患者，且静息状态下肺动脉压正常，经负荷多普勒超声心动图检查显示肺动脉收缩压异常升高的患者代表已经患有肺血管疾病并有发展为严重PAH风险的患者的一部分。我们进一步假设，早期识别和治疗这类患者可能会延缓疾病的进展。 假设： 1.负荷超声心动图通过检测系统性硬化症患者运动性肺动脉高压来识别早期肺血管疾病。 2.波生坦治疗运动性PAH可提高系统性硬化症患者的运动耐力。受试者将从那些运动试验异常的患者中招募，作为早期研究的一部分，运动超声心动图在硬皮病(IRB#03-363)。