Balloon pulmonary angioplasty combined with riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (PRACTICE study): study protocol for a randomized controlled trial
Qin-Hua Zhao,
Su-Gang Gong,
Jing He,
Ping Yuan,
Wen-Hui Wu,
Ci-Jun Luo,
Rong Jiang,
Rui Zhang,
Hong-Ling Qiu,
Hui-Ting Li,
Yuan Li,
Jin-Ming Liu,
Lan Wang
Affiliations
Qin-Hua Zhao
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Su-Gang Gong
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Jing He
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Ping Yuan
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Wen-Hui Wu
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Ci-Jun Luo
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Rong Jiang
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Rui Zhang
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Hong-Ling Qiu
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Hui-Ting Li
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Yuan Li
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Jin-Ming Liu
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Lan Wang
Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine
Abstract Background Management 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. Method This 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. Discussion This study aims to compare the efficacy and safety of BPA combined with riociguat and riociguat monotherapy for inoperable CTEPH. Trial registration Chinese Clinical Trial Registry ChiCTR2000032403 . Registered on 27 April 2020.
