临床试验/NCT03409588

NCT03409588已完成2 期

Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy

University of Colorado, Denver1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2018年6月13日最近更新: 2026年2月5日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: University of Colorado, Denver
入组人数: 10
试验地点: 1
主要终点: Change in cardiac output

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 100 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adult patients who underwent PTE or BPA for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation,
•able to give consent
•able to perform a exercise protocol

排除标准

•Patients with known Residual Pulmonary Hypertension (RPH) by RHC following PTE for CTEPH
•ongoing PAH-specific vasodilator therapy
•known contraindication to riociguat
•a physical limitation to completing an exercise protocol

研究组 & 干预措施

Study Drug

Experimental

Riociguat (Adempas) 0.5mg to 2.5 mg three time daily - oral medication

干预措施: Adempas (Drug)

结局指标

主要结局

Change in cardiac output

时间窗: Baseline and 3 months

Measurements include CO (cardiac output) mPAP/CO slope measured by right heart catheterization (RHC)

Change in mean pulmonary arterial pressure

时间窗: Baseline and 3 months

Measurements include mPAP (mean pulmonary arterial pressure) measured by right heart catheterization (RHC)

Change in Pulmonary artery compliance

时间窗: Baseline and 3 months

Measurements include Pulmonary artery compliance measured by right heart catheterization (RHC)

次要结局

Change in the University of California San Diego (UCSD) shortness of Breath Score(Baseline and 3 months)
Change in 6 minute walk test(Baseline and 3 months)
Change in New York Heart Association (NYHA) functional class(Baseline and 3 months)

研究者

发起方

University of Colorado, Denver

申办方类型

Other

责任方

Sponsor

研究点 (1)

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