Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000019549
• Date of registration: 28/10/2015
• Prospective Registration: Yes
• Primary sponsor: Keio University School of Medicine
• Public title: Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension
• Scientific title: Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension (MR BPA study)
• Date of first enrolment: 2016/04/01
• Target sample size: 60
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022608
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Keiichi Fukuda
• Affiliation: Keio University School of Medicine Department of Cardiology

• Name: Hiroki Takayama
• Affiliation: Soiken, Inc. Division of Clinical Study Support

Key inclusion & exclusion criteria

Inclusion criteria:
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: 20years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Chronic thromboembolic pulmonary hypertension (CTEPH)

Intervention(s)

Group A: BPA treatment Basically BPA treatment needs to be finished within 4 months from the day of first BPA session
Group B: Riociguat treatment First, starting with riociguat 3 times per day (1.0mg/time). Then increase the dose by 0.5mg every two weeks (with systolic blood pressure 95mmHg or higher). The maximum dose is 2.5mg per dose (three times per day). Dosage is adjusted accordingly for each patient, and the adjustment is finished within 4 months from the day of starting riociguat.

Primary Outcome(s)

Change in the mean pulmonary arterial 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 (QOL) parameters (EQ5D) from baseline to 12 months 14. Health insurance resource costs over 12 months

Source(s) of Monetary Support

Bayer Yakuhin, Ltd.

Ethics review

Status: YES
Approval date: 15/10/2015
Contact:

[e-mail]

the Institutional Review Board of Keio University School of Medicine

03-5363-3611

[e-mail]

Results

• Results available: Yes
• Date Posted: 08/05/2023
• Date Completed: 25/09/2020
• URL: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00171-0/fulltext