Why the study?
Management of inoperable chronic thromboembolic pulmonary hypertension remains challenging, and balloon pulmonary angioplasty has emerged as an alternative treatment alongside guideline-recommended riociguat.
Does balloon pulmonary angioplasty combined with riociguat improve pulmonary vascular resistance in subjects with inoperable chronic thromboembolic pulmonary hypertension compared to riociguat monotherapy?
Does balloon pulmonary angioplasty combined with riociguat improve pulmonary vascular resistance in subjects with inoperable chronic thromboembolic pulmonary hypertension compared to riociguat monotherapy?
This study protocol outlines a randomized trial to evaluate whether combining balloon pulmonary angioplasty with riociguat improves hemodynamics more than riociguat alone in patients with inoperable CTEPH.
BPA plus riociguat may improve outcomes versus monotherapy in inoperable CTEPH; extends limited RCT evidence and warrants larger confirmatory trials.
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.
No takes yet. Share an insight, caveat, or question.
Zhao et al. (2021) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: