Multicenter randomized controlled trial based on balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study)

Multicenter randomized controlled trial based on balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study) - Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021466

Enrollment

Registered

2016-03-14

Start date

2016-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic thromboembolic pulmonary hypertension (CTEPH)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are included: 1. Meet the CTEPH standard (based on the Japanese Circulation Society 2012 guideline) 2. Patients with class II or III of the WHO functional classification 3. Patients who are at age of 20 or older and younger than 80 years old at the time of giving their written consent 4. After consenting, average pulmonary artery pressure at right artery catheterization (RHC) checkup after giving their consent is 25mmHg or higher and below 60mmHg with pulmonary artery wedge pressure of 15mmHg or lower 5. Patients who have been on an appropriate anticoagulant therapy (PT-INR of 1.5 to 3.0) for three months or longer before consenting 6. Patients who are capable of providing their written consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in average pulmonary artery pressure from baseline to 12 months	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHiroki Takayama

Soiken Inc. Division of Clinical Study Support

takayama@soiken.com03-3295-1350

Outcome results