Clinical Study of Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension

NCT04326777 | Unknown

• 1 other identifier: 2019-KE-377
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Balloon pulmonary angioplasty(BPA); Chronic Thromboembolic Pulmonary Hypertension(CTEPH)

Outcome Measures

Primary Outcomes (2)

• To evaluate changes of baseline pulmonary vascular resistance (PVR) comparing to that of the final BPA and during follow-up period

  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.

  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 changes of baseline mean pulmonary artery pressure (mPAP) comparing to that of the final BPA and during follow-up period

  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.

  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 (4)

• 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

Study Arms (1)

Ballon pulmonary angioplasty

OTHER

Ballon pulmonary angioplasty(BPA) is a stepwise procedure requiring several separate sessions. The interval of a series of BPA is one month. In a series of BPA, there are 2 sessions, which are repeated at a 2-week interval. BPA is performed primarily on one side of the lung in the first session, then after 2 weeks, performed on the other side of the lung. In each session, the fluoroscopy time or the amount contrast are less than 60min and 200ml, respectively.

Procedure: Ballon pulmonary angioplasty

Interventions

Ballon pulmonary angioplasty PROCEDURE

Percutaneous vascular access for BPA is via the femoral vein using Seldinger technique. A 5Fr sheath is inserted into the vein, through which a 6Fr long introducer sheath is advanced into the pulmonary artery. Subsequently, a 6Fr guiding catheter is advanced into the pulmonary artery being treated. Generally, selective pulmonary angiography should be performed to evaluate lesion feature before BPA. Then a 0.014-inch guidewire is used to cross the lesion, a balloon catheter of an appropriate diameter is selected to dilate the lesion.

Ballon pulmonary angioplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Li Xuyan: lead

Study Sites (1)

Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University

Beijing, 100020, China

RECRUITING

Study Officials

• Yuanhua Yang, PhD

  Beijing Chao Yang Hospital

  STUDY CHAIR

Central Study Contacts

Yuanhua Yang, PhD

CONTACT

+8613911773607; yyh1031@sina.com

Wei Wang

CONTACT

+8615810262848; Vivian.Wang0622@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Respiratory and Critical Care Medicine,Beijing Institute of Respiratory Medicine, Beijing Chaoyang Hospital, Capital Medical University

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 30, 2020
• Study Start: April 15, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

CN (1)