Chronic thromboembolic pulmonary hypertension (CTEPH)
Conditions
Interventions
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 pe
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean pulmonary arterial pressure from baseline to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken, Inc. Division of Clinical Study Support
Outcome results
None listed