Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension: A Single-center, Prospective Long-term Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- To evaluate changes of baseline pulmonary vascular resistance (PVR) comparing to that of the final BPA and during follow-up period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To evaluate changes of baseline pulmonary vascular resistance (PVR) comparing to that of the final BPA and during follow-up period
Time Frame: 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
The study will measure pulmonary vascular resistance (PVR) at three time points (baseline before BPA, after final BPA, and follow-up) using right heart catheterization to assess pulmonary hemodynamics by comparing the changes of PVR at above 3 time points.
To evaluate changes of baseline mean pulmonary artery pressure (mPAP) comparing to that of the final BPA and during follow-up period
Time Frame: 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
The study will measure mean pulmonary artery pressure (mPAP) at three time points (baseline before BPA, after final BPA, and follow-up) using right heart catheterization to assess pulmonary hemodynamics by comparing the changes of mPAP at above 3 time points.
Secondary Outcomes
- To observe the complications associated with BPA(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)
- To observe changes of baseline mixed venous oxygen saturation (SvO2) comparing to the final BPA and during follow-up(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)
- To assess changes of baseline quality of life by calculating SF-36 score comparing to the final BPA and during follow-up(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)
- To evaluate long-term survival after the final BPA procedure and follow-up(at baseline, from enrollment to end of final BPA at 9 months, 1 year postoperative,2 year postoperative)
Investigators
Li Xuyan
Deputy Director of Respiratory and Critical Care Medicine,Beijing Institute of Respiratory Medicine, Beijing Chaoyang Hospital, Capital Medical University
Beijing Chao Yang Hospital