MR BPA study

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs031180239
• Date of registration: 12/03/2019
• Prospective Registration: No
• Primary sponsor: Fukuda Keiichi
• Public title: MR BPA study
• Scientific title: Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - MR BPA study
• Date of first enrolment: 14/04/2016
• Target sample size: 60
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs031180239
• Study type: Interventional
• Study design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
• Phase: N/A

Contacts

• Name: Keiichi Fukuda
• Affiliation: Keio University Hospital

• Name: Takashi Kawakami
• Affiliation: Keio University Hospital

Key inclusion & exclusion criteria

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.

Age minimum: >= 20age old
Age maximum: <= 80age old
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Thromboembolic Pulmonary Hypertension

Intervention(s)

Group A: BPA treatment
BPA is performed after allocation to this group (initial date of implementation will be the reference date). BPA will be completed within four months of the reference date.

Group B: Riociguat treatment
Riociguat treatment will be initiated after allocation to this group (the initial administration day will be the reference date). Riociguat will be initially administered three times per day at 1.0 mg per dose. Using systolic blood pressure (95 mmHg or higher) as a guide, the dose will be increased by 0.5 mg for each subject every two weeks with a thrice-daily administration of 2.5 mg/dose set as the maximum dosage. Dosage adjustment, including the maintenance dosage, is based on the judgment of the responsible investigators and investigators. Dosage adjustment will be completed within four months of the reference date.

Primary Outcome(s)

Change in the mean pulmonary artery pressure from baseline to 12 months

Secondary Outcome(s)

1. Changes in the six-minute walk distance from baseline to 12 months
2. Changes in the Borg dyspnea index from baseline to 12 months
3. Changes in hemodynamic variables, including pulmonary vascular resistance (PVR), mean right arterial pressure, and cardiac output] from baseline to 12 months
4. Changes in the WHO functional class
5. Changes in plasma brain natriuretic peptide (BNP) levels from baseline to 12 months
6. Changes in arterial oxygen saturation (SaO2) and oxygen partial pressure (PaO2) from baseline to 12 months
7. Changes in the usage volume of oxygen therapy from baseline to 12 months, including commencing oxygen therapy due to the exacerbation of a primary disease or dosage change.
8. Changes in pulmonary function test parameters from baseline to 12 months
9. Changes in echocardiography test parameters from baseline to 12 months
10. Frequency and severity of pulmonary artery injury assessed by chest X-ray and chest computed tomography (CT) scan
11. Frequency of adverse events
12. Clinical worsening during the observation period and time to clinical worsening (TTCW)
13. Change in Quality of Life parameters (EQ-5D-3L) from baseline to 12 months
14. Health insurance resource costs over 12 months

Secondary ID(s)

UMIN000019549

Source(s) of Monetary Support

Bayer Yakuhin, Ltd

Secondary Sponsor(s)

Kawakami Takashi

Ethics review

Status: Approval
Approval date: 28/02/2019
Contact:

[e-mail]

Certified Review Board of Keio

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 31/12/2022
• Date Completed: 25/09/2020