Balloon pulmonary angioplasty combined with riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (PRACTICE study): study protocol for a randomized controlled trial

Trials

Wen-Hui Wu¹  Rui Zhang¹  Yuan Li¹  Jin-Ming Liu¹  Jing He¹  Hong-Ling Qiu¹  Lan Wang¹  Ci-Jun Luo¹  Rong Jiang¹  Qin-Hua Zhao¹  Hui-Ting Li¹  Ping Yuan¹  Su-Gang Gong¹ 

[1] Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Zhengmin Road, 200433, Shanghai, China;

关键词: Randomized controlled trial;    Balloon pulmonary Angioplasty;    Riociguat;    Chronic thromboembolic Pulmonary hypertension;   

DOI  :  10.1186/s13063-021-05910-5

来源: Springer

【 摘 要 】

BackgroundManagement of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, riociguat, a soluble guanylate-cyclase stimulator is recommended by international guidelines. More recently, balloon pulmonary angioplasty (BPA) develops as an alternative treatment for inoperable CTEPH.MethodThis study is a single-center randomized controlled trial. Subjects with inoperable CTEPH are randomized into either a BPA combined with riociguat or riociguat monotherapy group (2:1) and observed for 12 months after initiation of treatment. The primary endpoint is the change in pulmonary vascular resistance from baseline to 12 months after initiation of treatment. The secondary endpoints include 6-min walk distance (6MWD), WHO-FC, NT-proBNP, SF-36, and other hemodynamic parameters. Safety endpoints are analyzed too.DiscussionThis study aims to compare the efficacy and safety of BPA combined with riociguat and riociguat monotherapy for inoperable CTEPH.Trial registrationChinese Clinical Trial Registry ChiCTR2000032403. Registered on 27 April 2020.

【 授权许可】

CC BY