Study on the improvement in exercise capacity in patients with inoperable chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty

Study on the improvement in exercise capacity in patients with inoperable chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty - Study on the improvement in exercise capacity in patients with inoperable chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015855

Enrollment

Registered

2015-01-01

Start date

2015-01-01

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as inoperable chronic thromboembolic pulmonary hypertension 1-1 Pulmonary hypertension is confirmed with right heart catheterization (mean pulmonary arterial pressure is equal to or higher than 25 mmHg and pulmonary artery wedge pressure is equal to or less than 15 mmHg at rest). 1-2 Peripheral thrombus is confirmed in pulmonary artery in contrast CT or pulmonary angiography. 1-3 Segmental blood perfusion defect is comfirmed by ventilation-perfusion scintigraphy. 1-4 Inoperable judgement is performed by a surgeon with experience for pulmonary endarterectomy. 2. Patients with WHO functional class 2, 3 and 4 3. Patients who understand study details with written consents.

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. History of allergic reaction to contrast medium 3. Cardiogenic shock 4. Severe liver dysfunction (Child-Pugh score C) 5. Renal dysfunction (serum creatinine levels is greater than or equal to 2.0 mg/dL) 6. Patients whose disadvantage in cardiopulmonary exercise test (CPX) is greater than benefits among one with relative conraindications for CPX 7. Contraindications for CPX 8. Patients who cannot keep supine position 9. Left heart failure 10. Patients who have received balloon pulmonary angioplasty (BPA) at the point of entry

Design outcomes

Primary

Measure	Time frame
Exercise capacity by cardiopulmonary exercise test	—

Secondary

Measure	Time frame
vascular endothelial function, sympton, hemodynamics by right heart catheterization, biomarkers by laboratory test	—

Countries

Japan

Contacts

Public ContactTkahisa Kondo

Nagoya University Graduate School of Medicine Advanced Medicine in Cardiopulmonary disease

takahisa@med.nagoya-u.ac.jp052-744-0388

Outcome results