Clinical trial NCT04326777: Clinical Study of Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension
Official title: Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension: A Single-center, Prospective Long-term Follow-up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Balloon pulmonary angioplasty(BPA)
Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic thromboembolic pulmonary hypertension (CTEPH) is the fourth group of pulmonary hypertension (PH) according to clinical classification. Pulmonary endarterectomy（PEA) is the preferred treatment for patients with CTEPH, however, PEA has its limitations, it only applies to the thrombi in the main, lobar, or segmental pulmonary arteries for patients with CTEPH, and the postoperative residual PH is found to be of high percentage. With the development of interventional techniques, balloon pulmonary angioplasty (BPA) has been used to treat chronic thrombotic pulmonary hypertension (CTEPH) with favorable results and has been identified as an effective and safe treatment for technically inoperable CTEPH. Balloon pulmonary angioplasty (BPA) has been accepted as a therapeutic strategy in accordance with the 2015 ESC/ESR guidelines, especially for patients with technically inoperable, an unfavorable risk-to-benefit ratio of the PEA. This study was a single-center prospective study that collects 3 time points data (before BPA, after final BPA, and follow-up ) to verify long-term safety and efficacy of BPA, as well as comparing the efficacy with targeted medical therapy, evaluating the complications of BPA, the survival of patients, and the postoperative quality of life.


Eligibility criteria: Inclusion Criteria:

* technically inoperable for PEA in patients with CTEPH
* unfavorable risk/benefit ratio for PEA
* residual or recurrent PH after PEA
* aged over 18 years old

Exclusion Criteria:

* other groups of PH except for CTEPH
* severe renal insufficiency(eGFR\<30ml/min·1.73mˆ2)
* severe infectious diseases
* severe hemorrhagic tendency
* severe anaphylaxis of contrast
* pregnancy and lactation
* expected survival time is less than half a year due to tumor or other disease

Primary outcomes:
measure: To evaluate changes of baseline pulmonary vascular resistance (PVR) comparing to that of the final BPA and during follow-up period
timeFrame: at baseline, from enrollment to end of final BPA at 9 months, at 3 months after BPA, at 9 months after BPA, at 15 months after BPA, at 27 months after BPA
measure: To evaluate changes of baseline mean pulmonary artery pressure (mPAP) comparing to that of the final BPA and during follow-up period
timeFrame: at baseline, from enrollment to end of final BPA at 9 months, at 3 months after BPA, at 9 months after BPA, at 15 months after BPA, at 27 months after BPA
Secondary outcomes:
measure: To observe the complications associated with BPA
timeFrame: at baseline, from enrollment to end of final BPA at 9 months, at 3 months after BPA, at 9 months after BPA, at 15 months after BPA, at 27 months after BPA
measure: To observe changes of baseline mixed venous oxygen saturation (SvO2) comparing to the final BPA and during follow-up
timeFrame: at baseline, from enrollment to end of final BPA at 9 months, at 3 months after BPA, at 9 months after BPA, at 15 months after BPA, at 27 months after BPA
measure: To assess changes of baseline quality of life by calculating SF-36 score comparing to the final BPA and during follow-up
timeFrame: at baseline, from enrollment to end of final BPA at 9 months, at 3 months after BPA, at 9 months after BPA, at 15 months after BPA, at 27 months after BPA
measure: To evaluate long-term survival after the final BPA procedure and follow-up
timeFrame: at baseline, from enrollment to end of final BPA at 9 months, 1 year postoperative,2 year postoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Yuanhua Yang, PhD
role: STUDY_CHAIR
References: