BOSENTAN VS PLACEBO IN NYHA CLASS L/LL SCLERODERMA PATIENTSW/PULMON HYPERTENSION

波生坦与安慰剂在 NYHA L/LL 级硬皮病患者/肺动脉高压患者中的比较

• 批准号: 7608469
• 负责人: VIRGINIA D STEEN
• 金额: $ 2.19万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608469
• 关键词: Class; Computer Retrieval of Information on Scientific Projects Database; Dyspnea; Echocardiography; Endothelin-1; Exercise; Funding; Grant; Hypertension; Institution; Invasive; Living Wills; Measurement; Observational Study; Outcome; Participant; Patients; Placebos; Protocols documentation; Pulmonary Hypertension; Quality of life; Questionnaires; Randomized; Research; Research Personnel; Resources; Scleroderma; Source; Standards of Weights and Measures; Stress; Systemic Scleroderma; Time; United States National Institutes of Health; Walking; Week; bosentan; hemodynamics; indexing; prospective; randomized placebo controlled trial

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. This is a prospective, randomized, placebo-controlled trial of Bosentan in systemic sclerosis patients with exercise-induced pulmonary hypertension. Subjects will be randomized to receive Bosentan 62.5 mg PO Bid x 1 month followed by 125 mg PO Bid thereafter versus placebo for 16 weeks. The primary outcome variable is total exercise time during the standard Bruce stress protocol with echocardiogram. The secondary outcome variables to be evaluated include: 6 minute walk distance, BMP levels, ET-1 levels, Short-Form 36 questionnaire, sHAQ, UCDS Dyspnea index. At the completion of 16 weeks, subjects will be eligible to receive long term Bosentan. Measurements of exercise endurance, non-invasive hemodynamics, and quality of life will be repeated every 6 months until the completion of the trial in 36 months as part of the PHRAOS long term (observational) study in which participants will be urged to enter, if they are not already a part of it.

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。 这是波森坦在全身性硬化症患者患有运动诱导的肺部高血压患者中的前瞻性，随机，安慰剂对照试验。受试者将被随机接受Bosentan 62.5毫克PO BID X 1个月，然后在16周内与安慰剂进行125毫克PO BID。主要结果变量是带有超声心动图的标准Bruce应力协议期间的总运动时间。 要评估的次要结果变量包括：6分钟步行距离，BMP水平，ET-1水平，短形式36问卷，SHAQ，UCDS呼吸困难指数。 在完成16周后，受试者将有资格获得长期波森坦。运动耐力，非侵入性血液动力学和生活质量的测量将每6个月重复一次，直到36个月内完成试验，这是Phraos长期（观察性）研究的一部分，如果他们尚未参加比赛，则敦促参与者进入，其中敦促参与者进入。