Multicenter randomized controlled trial based on balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study)
Not Applicable
- Conditions
- Chronic thromboembolic pulmonary hypertension (CTEPH)
- Registration Number
- JPRN-UMIN000021466
- Lead Sponsor
- Department of Cardiology, Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who meet any of the following criteria are excluded: 1. With a history of BPA treatment 2. Patients underwent PEA within 6 months before giving their written consent 3. Currently using any unapproved medicine (by Japanese authorities). 4. Patients who used any pulmonary vasodilatation agents within 4 weeks before RHC checkup after giving consent 5. Complicated with pulmonary hypertension but are not type IV of Nice classification 6. Pregnant or breastfeeding 7. Patients who are prohibited to use riociguat 8. Life expectancy less than 2 years 9. Patients who are judged by physicians/investigators to be inappropriate to participate in the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in average pulmonary artery pressure from baseline to 12 months
- Secondary Outcome Measures
Name Time Method 1. Change in the 6-minute walk distance (6MWD) from baseline to 12 months 2. Change in Borg Dyspnea Index from baseline to 12 months 3. Change in a hemodynamic index (pulmonary vascular resistance, average right atrial pressure, and cardiac output) from baseline to 12 months 4. Change of WHO functional classification 5. Change of plasma BNP concentration 6. Change in SaO2 and PaO2 from baseline to 12 months 7. Change in use of oxygen therapy (including initiation of oxygen therapy for deteriorated iatrogenic disease and change of the amount of use) 8. Change in each parameter of pulmonary function test at 12 months 9. Change in each parameter of echocardiography at 12 months 10. Frequency and severity of lung injury determined by chest X-ray and CT images 11. Occurrence of adverse events 12. Time to clinical worsening (TTCW) during the observation period 13. Change in QOL (EQ5D-3L) parameters 14. Expense of the health insurance resources during the 12 months