MR BPA study

Not Applicable

• Conditions: Chronic Thromboembolic Pulmonary Hypertension

• Registration Number: JPRN-jRCTs031180239
• Lead Sponsor: Fukuda Keiichi

Brief Summary

Among patients with inoperable CTEPH, BPA improved the clinically relevant haemodynamic and functional outcomes compared with riociguat in monotherapy, although procedure related complications were seen. These findings support that BPA can be a reasonable option for inoperable CTEPH in experienced centres, with attention to proce dure related complications.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Study Completion: 2020-09-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Patients meeting the following criteria will be included in the study.
(a) patients who are diagnosed with CTEPH (based on the diagnostic criteria in the 2012 Japanese Circulation Society guidelines with a WHO functional class II or III).
(b) male and female aged >= 20 years and < 80 years.
(c) patients with mean pulmonary arterial pressure of >= 25 mmHg to < 60 mmHg and pulmonary artery wedge pressure of =< 15 mmHg.
(d) patients who undergo appropriate anticoagulant therapy for at least three months prior to consent acquisition (if warfarin is used, prothrombin time-international normalized ratio should be 1.5 to 3.0).
(e) patients who provide written consent form to participate in this study after full explanation of the study.

Exclusion Criteria

Patients meeting any of the following exclusion criteria will be excluded from the trial.
(a) patients with a history of BPA.
(b) patients who underwent PEA within six months prior to consent acquisition.
(c) patients who are using unapproved pharmaceutical products.
(d) patients who used a pulmonary vasodilator within four weeks prior to the right heart catheterization after consent acquisition.
(e) patients with co-existing etiology of pulmonary hypertension other than Group 4 in the Nice Pulmonary Hypertension Classification System.
(f) patients who are pregnant or breastfeeding.
(g) patients who met the contraindication for riociguat.
(h) patients whose life expectancy is less than two years.
(i) patients who are considered to be unsuitable for participation by investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified