Chronic Thromboembolic Pulmonary HypertensionNCT02964390
Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients
A study testing Balloon Pulmonary Angioplasty in people with Chronic Thromboembolic Pulmonary Hypertension, run by Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med at 1 site in Poland.
Trial summary
Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option 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 patients disqualified from surgery or suffered from persistent CTEPH despite… 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?
- Balloon Pulmonary Angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2013to Dec 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
- diagnosed with CTEPH according to ESC Guidelines
- WHO functional capacity ≥ II
- documented period of anticoagulation > 6 months after the episode of Pulmonary Embolism,
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
European Health Center Otwock
Otwock, 05-400
Marcin Kurzyna, MD, PhD, +48-22-7103052, marcin.kurzyna@ecz-otwock.pl
Szymon Darocha, MD, +48-22-710-30-54, szymon.darocha@gmail.com
About this study
Official title: Assessment of Safety and Efficacy of Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients
Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option 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 patients disqualified from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy.
This is a interventional study analyzing the benefits and the risk of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, haemodynamics, biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL assessment with Short Form 36 (SF36) questionnaire was performed before the initiation therapy of BPA, and 3-6 months after last session of BPA.
Read the detailed description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but potentially life-threatening disease of the pulmonary circulation. Management of CTEPH requires precise differential diagnosis, long life anticoagulation when confirmed and qualification for surgical treatment by an experienced multidisciplinary team. The gold standard of treatment in operable patients is pulmonary endarterectomy (PEA), which is highly effective in restoring functional status and improving life expectancy. Nevertheless, even in the leading CTEPH referral centres almost 50% patients remain on medical treatment alone, with grim perspectives regarding life quality and expectancy. Recently, balloon pulmonary angioplasty (BPA) has emerged as a promising new interventional option in non-operable CTEPH.
The development BPA was far from rapid. It took 13 years from the first case-report to the publication of a first series of 17 patients treated with BPA in Boston/US and another 13 years until the results of first European series of 20 patients has been reported from Oslo/Norway. In Poland BPA was started to perform in non-operable CTEPH patients in 2013, motivated by their expected poor prognosis, when compared to those to whom surgical PEA was offered.
The aim of this study is an analysis of efficacy and safety of BPA procedure.
The BPA is performed by two senior interventional specialist - cardiologist and radiologist with extensive experience in coronary, pulmonary and general vessel interventions supported by perfusion nurse. All patients undergoing BPA are given informed consent before the first BPA intervention. The limited experience with and experimental nature of BPA are emphasised to candidates.
A standard BPA procedure is typically performed from the right femoral vein, with anticoagulation of unfractionated heparin in periprocedural period. A long (70 or 90 cm) sheath is introduced into the pulmonary trunk with support of pigtail catheter. Selective and super-selective catheterisation of lobar arteries, segmental and when appropriate subsegmental arteries is performed to demonstrate variety of clots: "webs", "rings", "occlusions", "pouch" lesions and reduction of parenchymal opacification after injection of vascular contrast medium. Balloon catheters (diameter 1.25-6.0 mm) are positioned over the selected lesion and dilated for several seconds. Immediate selective angiography is performed after dilation to confirm satisfactory results which presented the improvement of contrast medium distribution and venous return. Control angiography is done to rule out residual stenosis or signs of vessel injury. Following BPA procedure, patients are moved to ICU for 48 h surveillance.
Right before the initiation of BPA and during 3-6 months after last session, a full workup is made, including: World Health Organization (WHO) functional class, 6-minute walking test (6MWT), concentration of biomarkers (NT-proBNP, Troponin T, sST2), cardiopulmonary exercise test, echocardiography, electrocardiography and right heart catheterization including measurements of right atrial pressure (RAP), pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), cardiac index (CI), pulmonary vascular resistance (PVR), mixed venous oxygenation (MVsat.O2) and systemic oxygenation (AOsatO2). Additionally patients fill in the Short Form 36 (SF36) quality of life questionnaire before initiation of BPA and 3-6 months after last session.
- Being tested
- Balloon Pulmonary Angioplasty
- Keywords
- CTEPH, balloon pulmonary angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Pulmonary AngioplastyProcedure or surgery
Also called BPA
| Study group | Role | What they receive |
|---|---|---|
| Balloon Pulmonary Angioplasty | Experimental | This arm includes patients qualified to BPA procedure. They have a baseline workup performed before the initiation of BPA treatment and had a follow up examination from 3 to 6 months after the last BPA session. Receives: Procedure: Balloon Pulmonary Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of BPA procedure.
Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death.
Measured: From initiation of BPA to 3-6 months after last session
Improvement of haemodynamics caused by series of BPA.
Measurements taken during right heart catheterization in at least 25 patients with accomplished interventional treatment of BPA. The measurements will include pulmonary artery pressure - PAP [mmHg].
Measured: From initiation of BPA to 3-6 months after last session
Improvement of functional capacity caused by series of BPA.
Examined using World Health Organization (WHO) functional capacity classification is evaluated by physician in every patient, on admission and follow up.
Measured: From initiation of BPA to 3-6 months after last session.
Improvement of NT-proBNP caused by series of BPA.
Baseline measurements of the concentration of NT-proBNP [pg/ml] in at least 25 subjects who accomplished their invasive treatment.
Measured: From initiation of BPA to 3-6 months after last session.
Improvement of six minutes walk test caused by series of BPA.
Six minutes walking test - 6MWT is performed according to European Society of Cardiology (ESC) guidelines. The baseline distance [meters] covered during the 6MWT will be compared to the follow up value in patients (at least 25) who accomplished their invasive treatment of BPA.
Measured: From initiation of BPA to 3-6 months after last session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJul 2013
- Primary completionJun 2023 (estimated)
- Study completionDec 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Kurzyna, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
- Investigators
- Marcin Kurzyna, MD,PhD, Principal investigator, European Health Center Otwock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964390
- Sponsor's protocol ID
- 002
- Status last verified
- Aug 2021
- First submitted
- 6 Sep 2016
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients
- ClinicalTrials.gov ID
- NCT02964390
- Acronym / sponsor ID
- 002
- Keywords
- CTEPH, balloon pulmonary angioplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate MedUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- 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.
Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option 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 patients disqualified from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy.
This is a interventional study analyzing the benefits and the risk of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, haemodynamics, biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL assessment with Short Form 36 (SF36) questionnaire was performed before the initiation therapy of BPA, and 3-6 months after last session of BPA.
Detailed description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but potentially life-threatening disease of the pulmonary circulation. Management of CTEPH requires precise differential diagnosis, long life anticoagulation when confirmed and qualification for surgical treatment by an experienced multidisciplinary team. The gold standard of treatment in operable patients is pulmonary endarterectomy (PEA), which is highly effective in restoring functional status and improving life expectancy. Nevertheless, even in the leading CTEPH referral centres almost 50% patients remain on medical treatment alone, with grim perspectives regarding life quality and expectancy. Recently, balloon pulmonary angioplasty (BPA) has emerged as a promising new interventional option in non-operable CTEPH.
The development BPA was far from rapid. It took 13 years from the first case-report to the publication of a first series of 17 patients treated with BPA in Boston/US and another 13 years until the results of first European series of 20 patients has been reported from Oslo/Norway. In Poland BPA was started to perform in non-operable CTEPH patients in 2013, motivated by their expected poor prognosis, when compared to those to whom surgical PEA was offered.
The aim of this study is an analysis of efficacy and safety of BPA procedure.
The BPA is performed by two senior interventional specialist - cardiologist and radiologist with extensive experience in coronary, pulmonary and general vessel interventions supported by perfusion nurse. All patients undergoing BPA are given informed consent before the first BPA intervention. The limited experience with and experimental nature of BPA are emphasised to candidates.
A standard BPA procedure is typically performed from the right femoral vein, with anticoagulation of unfractionated heparin in periprocedural period. A long (70 or 90 cm) sheath is introduced into the pulmonary trunk with support of pigtail catheter. Selective and super-selective catheterisation of lobar arteries, segmental and when appropriate subsegmental arteries is performed to demonstrate variety of clots: "webs", "rings", "occlusions", "pouch" lesions and reduction of parenchymal opacification after injection of vascular contrast medium. Balloon catheters (diameter 1.25-6.0 mm) are positioned over the selected lesion and dilated for several seconds. Immediate selective angiography is performed after dilation to confirm satisfactory results which presented the improvement of contrast medium distribution and venous return. Control angiography is done to rule out residual stenosis or signs of vessel injury. Following BPA procedure, patients are moved to ICU for 48 h surveillance.
Right before the initiation of BPA and during 3-6 months after last session, a full workup is made, including: World Health Organization (WHO) functional class, 6-minute walking test (6MWT), concentration of biomarkers (NT-proBNP, Troponin T, sST2), cardiopulmonary exercise test, echocardiography, electrocardiography and right heart catheterization including measurements of right atrial pressure (RAP), pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), cardiac index (CI), pulmonary vascular resistance (PVR), mixed venous oxygenation (MVsat.O2) and systemic oxygenation (AOsatO2). Additionally patients fill in the Short Form 36 (SF36) quality of life questionnaire before initiation of BPA and 3-6 months after last session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balloon Pulmonary Angioplasty | Experimental | Procedure: Balloon Pulmonary AngioplastyThis arm includes patients qualified to BPA procedure. They have a baseline workup performed before the initiation of BPA treatment and had a follow up examination from 3 to 6 months after the last BPA session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with CTEPH according to ESC Guidelines
- WHO functional capacity ≥ II
- documented period of anticoagulation > 6 months after the episode of Pulmonary Embolism,
Key exclusion criteria (1 listed)
- age < 18 years
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 |
|---|---|---|
| Balloon Pulmonary AngioplastyAlso: BPA | Procedure or surgery | Balloon Pulmonary Angioplasty |
Primary outcome
Safety of BPA procedure.
Time frame: From initiation of BPA to 3-6 months after last session
Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death.
Improvement of haemodynamics caused by series of BPA.
Time frame: From initiation of BPA to 3-6 months after last session
Measurements taken during right heart catheterization in at least 25 patients with accomplished interventional treatment of BPA. The measurements will include pulmonary artery pressure - PAP [mmHg].
Improvement of functional capacity caused by series of BPA.
Time frame: From initiation of BPA to 3-6 months after last session.
Examined using World Health Organization (WHO) functional capacity classification is evaluated by physician in every patient, on admission and follow up.
Improvement of NT-proBNP caused by series of BPA.
Time frame: From initiation of BPA to 3-6 months after last session.
Baseline measurements of the concentration of NT-proBNP [pg/ml] in at least 25 subjects who accomplished their invasive treatment.
Improvement of six minutes walk test caused by series of BPA.
Time frame: From initiation of BPA to 3-6 months after last session.
Six minutes walking test - 6MWT is performed according to European Society of Cardiology (ESC) guidelines. The baseline distance [meters] covered during the 6MWT will be compared to the follow up value in patients (at least 25) who accomplished their invasive treatment of BPA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Marcin Kurzyna, MD,PhD principal investigator
European Health Center Otwock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Pulmonary Angioplasty in people with Chronic Thromboembolic Pulmonary Hypertension, run by Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med at 1 site in Poland.
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 3 inclusion and 1 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 19 Aug 2021. 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 Poland. 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 Marcin Kurzyna, MD, PhD (+48-22-7103052, marcin.kurzyna@ecz-otwock.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of BPA procedure. (time frame: From initiation of BPA to 3-6 months after last session). The study lists 5 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 19 Aug 2021.