Clinical trial NCT04206852: Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Official title: Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Lead sponsor: Chinese Pulmonary Vascular Disease Research Group
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic thromboembolic pulmonary hypertension patients admitted in hospital.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events of BPA procedure.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of Pulmonary artery pressure in mmHg caused by series of BPA.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of cardiac index (CI) in L/m^2 caused by series of BPA.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of World Health Organization (WHO) functional capacity classification caused by series of BPA.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of six minutes walk distance in meter caused by series of BPA.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of Peak VO2/kg in ml/min/kg caused by series of BPA.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of diffusing capacity for carbon monoxide caused by series of BPA.
timeFrame: From initiation of BPA to 3-12 months after last session
measure: Change of fibroblast activation protein inhibitor expression after BPA
timeFrame: From initiation of BPA to 3-12 months after last session
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: center of pulmonary vascular disease, Fuwai hospital
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Fuwai hospital
Study officials:
References: