Chronic Thromboembolic Pulmonary HypertensionNCT04326777
Clinical Study of Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension
A study testing Ballon pulmonary angioplasty in people with Chronic Thromboembolic Pulmonary Hypertension, run by Li Xuyan at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Ballon pulmonary angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Institute of Respiratory Medicine, Beijing Chao-yang Hospital, Capital Medical University
Beijing, 100020
Xuyan Li, +8613581851048, araklee@163.com
About this study
Official title: Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension: A Single-center, Prospective Long-term Follow-up Study
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.
- Being tested
- Ballon pulmonary angioplasty
- Keywords
- Balloon pulmonary angioplasty(BPA), Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballon pulmonary angioplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ballon pulmonary angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The principal complications associated with BPA are pulmonary edema and pulmonary vascular injury, which may lead to symptoms such as hemoptysis, coughing or hypoxia. The study will collect data to assess the incidence of complication and identify risk factor for complications of BPA procedure.
Measured: 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
Patients with CTEPH commonly manifest hypoxia and decreased exercise capacity due to lower respiratory efficiency. This study will collect oxygen-dynamic data associated with BPA to evaluate respiratory efficiency.
Measured: 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
It has been proved that BPA improve hemodynamic in patients with inoperable CTPEH, but the effect of BPA on QoL has rarely been reported. Each patient will be asked to fill out the SF-36v2 QoL questionnaire before BPA, after final BPA and follow-up period. QoL will be evaluated on 8 scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE) and mental health (MH).Then the investigator will collect 3 time points data to assess changes of QoL in patient with CTEPH.
Measured: 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
The primary end point for overall survival analysis is all-cause death. Long-term survival from the initial BPA procedure, the final BPA procedure and follow-up period will be evaluated.
Measured: at baseline, from enrollment to end of final BPA at 9 months, 1 year postoperative,2 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start15 Apr 2020
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Xuyan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Xuyan, Beijing Chao Yang Hospital
- Investigators
- Yuanhua Yang, PhD, Study chair, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326777
- Sponsor's protocol ID
- 2019-KE-377
- Status last verified
- May 2020
- First submitted
- 27 Mar 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Pulmonary Angioplasty for Patients With Chronic Thromboembolic Pulmonary Hypertension: A Single-center, Prospective Long-term Follow-up Study
- ClinicalTrials.gov ID
- NCT04326777
- Acronym / sponsor ID
- 2019-KE-377
- Keywords
- Balloon pulmonary angioplasty(BPA), Chronic Thromboembolic Pulmonary Hypertension(CTEPH)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Li XuyanUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ballon pulmonary angioplasty | Other | Procedure: Ballon pulmonary angioplastyBallon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ballon pulmonary angioplastyPercutaneous 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. | Procedure or surgery | Ballon pulmonary angioplasty |
Primary outcome
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.
4 secondary outcomes
To observe the complications associated with BPA
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
To observe changes of baseline mixed venous oxygen saturation (SvO2) comparing to the final BPA and during follow-up
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
To assess changes of baseline quality of life by calculating SF-36 score comparing to the final BPA and during follow-up
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
To evaluate long-term survival after the final BPA procedure and follow-up
Time frame: at baseline, from enrollment to end of final BPA at 9 months, 1 year postoperative,2 year postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanhua Yang, PhD study chair
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ballon pulmonary angioplasty in people with Chronic Thromboembolic Pulmonary Hypertension, run by Li Xuyan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanhua Yang, PhD (+8613911773607, yyh1031@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.