Chronic Thromboembolic Pulmonary Hypertension
Conditions
Brief summary
Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH). The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.
Detailed description
This study is a prospective, multi-center, long-term observational project to study the safety and efficacy of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of BPA, and 3-12 months after last session of BPA. we also aim to evaluate the value of FAPI in predicting the efficacy and the prognosis of patients with CTEPH who received BPA.
Interventions
PROCEDUREBalloon pulmonary angioplasty
Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
Sponsors
Chinese Pulmonary Vascular Disease Research Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines 2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH 3. Not amenable to pulmonary endarterectomy 4. Willing to provide informed consent
Exclusion criteria
1. Patients unwilling or unable to provide written consent for participation in the study. 2. Impossible to follow up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events of BPA procedure. | From initiation of BPA to 3-12 months after last session | Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (\<50ml), severe hemoptysis (\>50ml), reperfusion pulmonary injury, death. |
| Change of Pulmonary artery pressure in mmHg caused by series of BPA. | From initiation of BPA to 3-12 months after last session | Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization. |
| Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA. | From initiation of BPA to 3-12 months after last session | Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization. |
| Change of cardiac index (CI) in L/m^2 caused by series of BPA. | From initiation of BPA to 3-12 months after last session | Cardiac index (CI) in L/m\^2 is obtained by right cardiac catheterization. |
| Change of World Health Organization (WHO) functional capacity classification caused by series of BPA. | From initiation of BPA to 3-12 months after last session | World Health Organization is obtained from electronic medical records. |
| Change of six minutes walk distance in meter caused by series of BPA. | From initiation of BPA to 3-12 months after last session | World Health Organization is obtained from electronic medical records. |
| Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA. | From initiation of BPA to 3-12 months after last session | World Health Organization is obtained from electronic medical records. |
| Change of Peak VO2/kg in ml/min/kg caused by series of BPA. | From initiation of BPA to 3-12 months after last session | Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test. |
| Change of diffusing capacity for carbon monoxide caused by series of BPA. | From initiation of BPA to 3-12 months after last session | diffusing capacity for carbon monoxide in % is obtained from pulmonary function test |
| Change of fibroblast activation protein inhibitor expression after BPA | From initiation of BPA to 3-12 months after last session | Change of fibroblast activation protein inhibitor expression after BPA |
Countries
China
Contacts
Primary ContactZhihong Liu, doctor
Outcome results
None listed