scholarly journals 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 ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Qin-Hua Zhao ◽  
Su-Gang Gong ◽  
Jing He ◽  
Ping Yuan ◽  
Wen-Hui Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pulmonary Hypertension ◽  
Soluble Guanylate Cyclase ◽  
Controlled Trial ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Balloon Pulmonary Angioplasty ◽  
Thromboembolic Pulmonary Hypertension ◽  
Group 2

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.

scholarly journals Multicentre randomised controlled trial of balloon pulmonary angioplasty and riociguat in patients with chronic thromboembolic pulmonary hypertension: protocol for the MR BPA study

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e028831 ◽  
Author(s):  
Takashi Kawakami ◽  
Hiromi Matsubara ◽  
Kohtaro Abe ◽  
Masaharu Kataoka ◽  
Shun Kohsaka ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Randomised Controlled Trial ◽  
Soluble Guanylate Cyclase ◽  
Pulmonary Arterial Pressure ◽  
Controlled Trial ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Balloon Pulmonary Angioplasty ◽  
Thromboembolic Pulmonary Hypertension ◽  
Pulmonary Arterial ◽  
Randomised Controlled

IntroductionManagement of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, medical treatment involving pulmonary vasodilators (such as soluble guanylate-cyclase stimulators) is recommended, primarily for ameliorating symptoms. More recently, balloon pulmonary angioplasty (BPA) has been developed as alternative treatment for inoperable CTEPH. This study aimed to compare the efficacy and safety of BPA and riociguat (a soluble guanylate-cyclase stimulator) as treatments for inoperable CTEPH.Methods and analysisThis study is a multicentre randomised controlled trial. Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment. The primary endpoint will be the change in mean pulmonary arterial pressure from baseline to 12 months after initiation of treatment. For primary analysis, we will estimate the least square means difference and 95% CI for the change of pulmonary arterial pressure between the groups at 12 months using the analysis of covariance adjusted for allocation factors.Ethics and disseminationThis study and its protocols were approved by the institutional review board of Keio University School of Medicine and each participating institution. Written informed consent was obtained from all participants. Results will be disseminated at medical conferences and in journal publications.Trial registration numberUniversity Hospital Medical Information Network Clinical Trial Registry (UMIN000019549); Pre-results.

New interventions to treat chronic thromboembolic pulmonary hypertension

Heart ◽  
2018 ◽  
Vol 104 (18) ◽  
pp. 1480-1483 ◽  
Author(s):  
David Jenkins
Keyword(s):  
Pulmonary Hypertension ◽  
Vascular Resistance ◽  
Controlled Trial ◽  
Case Series ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Definitive Treatment ◽  
Dramatic Improvement ◽  
Complication Rates ◽  
Balloon Pulmonary Angioplasty ◽  
Thromboembolic Pulmonary Hypertension

Chronic thromboembolic pulmonary hypertension (CTEPH) can be defined as a type of precapillary pulmonary hypertension (PH) resulting from incomplete resolution of pulmonary embolism. Symptoms are exertional breathlessness and most patients come to a cardiologist’s attention with a dilated right heart on echocardiography. Patients with suspected CTEPH should be referred for evaluation to a PH specialist centre to confirm the diagnosis. There are now three treatment options available, dependent on the anatomical level of the obstruction: pulmonary endarterectomy surgery, balloon pulmonary angioplasty and pulmonary arterial hypertension (PAH)-targeted drugs. All reduce pulmonary artery pressure and vascular resistance. Current guidelines recommend surgery as the definitive treatment in technically operable patients. The operation involves deep hypothermic circulatory arrest, but the in-hospital mortality is <5% and the 3-year survival is 90%. Large case series have demonstrated dramatic improvement in haemodynamic parameters with significant symptomatic and prognostic benefits. Balloon pulmonary angioplasty is the newest treatment that has been refined by Japanese cardiologists over the last 5 years. This technique is designed to target more distal subsegmental lesions in inoperable patients and in experienced centres has been shown to deliver equivalent haemodynamic improvement to surgery with low complication rates, but longer term outcome is still under evaluation. A recent randomised controlled trial has demonstrated a reduction in vascular resistance and increase in walk test distance with the PAH-targeted drug Riociguat in patients with inoperable CTEPH, and this drug is now licensed for these patients. It is likely that some patients will benefit from combinations of treatments.

scholarly journals Soluble ST2 as a Biomarker for Early Complications in Patients with Chronic Thromboembolic Pulmonary Hypertension Treated with Balloon Pulmonary Angioplasty

Diagnostics ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 133
Author(s):  
Marta Banaszkiewicz ◽  
Arkadiusz Pietrasik ◽  
Michał Florczyk ◽  
Piotr Kędzierski ◽  
Michał Piłka ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Troponin T ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Early Complications ◽  
Dynamic Changes ◽  
Soluble St2 ◽  
Time Points ◽  
Balloon Pulmonary Angioplasty ◽  
Thromboembolic Pulmonary Hypertension ◽  
Discharge From Hospital

Background: The aim of the study was to assess soluble ST2 (sST2) concentration and its dynamic changes in the periprocedural period in patients with chronic thromboembolic pulmonary hypertension (CTEPH) treated with balloon pulmonary angioplasty (BPA). Methods: We prospectively analyzed 57 procedures of BPA performed in 37 patients with CTEPH. Biomarkers, such as N-terminal pro B-type natriuretic peptide (NT-proBNP), troponin T (TnT), and sST2 were assessed at four time points: Before the BPA procedure, 24 h and 48 h after the procedure, and at the discharge from hospital. Each postprocedural period was assessed for complications. Results: Before the BPA procedure, median sST2 concentration was 26.56 ng/mL (IQR: 16.66–40.83 ng/mL). sST2 concentration was significantly higher 24 h and 48 h after the BPA compared to the baseline measurements (33.31 ng/mL (IQR: 20.81–62.56), p = 0.000 and 27.45 ng/mL (IQR: 17.66–54.45), p = 0.028, respectively). sST2 level 24 h after the BPA procedure was significantly higher in the group with complications compared to the group without complications in the postprocedural period (97.66 ng/mL (IQR: 53.07–126.18) vs. 26.86 ng/mL (IQR: 19.10–40.12), p = 0.000). Conclusions: sST2 concentration in patients with CTEPH treated with BPA changes significantly in the postprocedural period and is significantly higher in the group with complications in postprocedural period.

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