Chronic thromboembolic pulmonary disease (CTEPD) with mean pulmonary artery pressure below 25 mmHg
Conditions
Interventions
Intervention: Balloon Pulmonary Angioplasty (BPA) Group
Participants allocated to the BPA group will undergo balloon pulmonary angioplasty (BPA) after randomization. Because BPA is performed in addit
therefore, the planned BPA treatment course should be completed within 4 months of the initial BPA procedure.
Although a minimum of two BPA sessions is recommended, early completion of BPA treatment i
Sponsors
Satoh Taijyu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and provision of written informed consent. 2. Symptomatic disease, defined as a modified Medical Research Council (mMRC) dyspnea scale score of >=1. 3. Imaging-confirmed chronic thromboembolic pulmonary disease (CTEPD), defined by at least one of the following: - Organized thrombi, webs, bands, or mosaic perfusion patterns identified on computed tomography pulmonary angiography (CTPA) or catheter-based pulmonary angiography (PAG); or - Persistent mismatched perfusion defects on ventilation-perfusion (V/Q) scintigraphy or single-photon emission computed tomography (SPECT). These findings must be confirmed after at least 3 months of therapeutic anticoagulation. 4. Right heart catheterization performed within 180 days prior to initiation of the study intervention, demonstrating: - Mean pulmonary artery pressure (mPAP) <25 mmHg - Pulmonary artery wedge pressure (PAWP) <=15 mmHg - Measurable cardiac output (CO) 5. Considered technically suitable for balloon pulmonary angioplasty (BPA) by the treating physician. 6. Able to undergo cardiopulmonary exercise testing (CPET). 7. Able to complete the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).
Exclusion criteria
Exclusion criteria: 1.Presence of respiratory disease requiring active treatment. 2.Presence of orthopedic or musculoskeletal disorders that significantly limit exercise capacity. 3.Ongoing anticancer therapy that has been initiated or modified within the previous 6 months, or for which modification is planned during the study period. 4.Estimated life expectancy of less than 1 year. 5.Systolic systemic blood pressure 2 times the upper limit of normal). 8.Predominantly central thromboembolic lesions considered suitable for pulmonary endarterectomy (PEA) as the first-line treatment. 9.Current treatment with pulmonary vasodilators for pulmonary hypertension (use for connective tissue disease is permitted). 10.Pregnancy or breastfeeding. 11.Previous treatment with balloon pulmonary angioplasty (BPA) or pulmonary endarterectomy (PEA). 12.Any condition that, in the opinion of the principal investigator, would make participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak oxygen uptake (peak VO2; mL/kg/min) measured by cardiopulmonary exercise testing (CPET) from baseline to 6 months after enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SF-36 score from baseline to 6 months after enrollment. Change in 6-minute walk distance, hemodynamic parameters, and oxygenation during the 6-minute walk test from baseline to 6 months after enrollment. Change in pulmonary vascular resistance (PVR) measured by right heart catheterization at rest from baseline to 6 months after enrollment. Change in World Health Organization functional class (WHO-FC) from baseline to 6 months after enrollment. Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels from baseline to 6 months after enrollment. Change in the mPAP/CO slope from baseline to 6 months after enrollment. Hospitalization for the development or worsening of heart failure or pulmonary hypertension, and all-cause mortality during follow-up after enrollment. | — |
Contacts
Public ContactTaijyu Satoh
Tohoku University Graduate School of Medicine
Outcome results
None listed