Chronic Thromboembolic Pulmonary HypertensionNCT03245268
International BPA Registry
An observational study of Chronic Thromboembolic Pulmonary Hypertension and CTEPH, run by International CTEPH Association at 18 sites in 10 countries.
Trial summary
The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension, CTEPH
- What is being tested?
- Balloon pulmonary angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 18 sitesin 10 countries
- Study dates
- 2 Mar 2018to 31 Mar 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with CTEPH meeting the inclusion criteria listed below and scheduled to undergo BPA intervention are eligible for inclusion into the International BPA Registry.
Who may be able to join
- Diagnosis with CTEPH according to the following criteria:
- Mean PAP ≥ 25mmHg at rest; or if mean PAP < 25mmHg at rest, have exercise limitations from chronic thromboembolic disease
- Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
- Naïve to BPA treatment
- Scheduled to undergo their first BPA session ≥ 1 day after enrollment. Enrollment is defined as date the consent is signed by the patient. Enrollment must occur before any BPA session
- Willing to provide informed consent
Who cannot join
- BPA treatment prior to enrollment
- Pulmonary hypertension cause other than World Health Organization (WHO) group IV (CTEPH)
- Targeted BPA treatment lesion other than from WHO group IV (CTEPH)
Trial locations and contacts
18 sites in 10 countries.
18 sites in 10 countries
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
University of California San Diego
La Jolla, California, 92093
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Mayo Clinic
Rochester, Minnesota, 55905
Japan4 sites
National Hospital Organization Okayama Medical Center
Okayama
National Cerebral and Cardiovascular Center
Osaka
Keio University Hospital
Tokyo
Kyorin University Hospital
Tokyo
France2 sites
Centre Hospitalier Universitaire Grenoble-Alpes
Grenoble
L'Hôpital Marie Lannelongue
Le Plessis-Robinson
About this study
The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).
- Being tested
- Balloon pulmonary angioplasty
- Keywords
- Balloon pulmonary angioplasty, BPA
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
BPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by BPA-associated complications
Measured: Min. 2 years
Efficacy as assessed by change in PVR
Change in pulmonary vascular resistance (PVR) from baseline to latest post-interventional follow-up hemodynamics
Measured: Min. 2 years
Efficacy as assessed by change in mPAP
Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics
Measured: Min. 2 years
Secondary outcomes (11)
Compare volume of BPA cases across regions and case load at the end of recruitment
Measured: Min. 2 years
Analyze patient selection criteria for BPA across sites at the end of recruitment
Measured: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites
Imaging modalities encompass VQ scan, selective pulmonary angiogram, CT pulmonary angiogram, dual-energy CT, cone-beam CT, MRI, OCT and IVUS
Measured: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals
Measured: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by number of sessions per patient and follow-up
Measured: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by number of interventions per patient and follow-up
Measured: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by technical limits
Measured: Min. 2 years
Analyze the use of PH targeted medical therapy before BPA
PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other
Measured: Min. 2 years
Analyze the use of PH targeted medical therapy after BPA
PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other
Measured: Min. 2 years
Analyze the impact of PH targeted medical treatment on key patient outcomes
PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other Key patient outcomes encompass WHO functional class, 6-minute-walk-distance, Borg dyspnoe score, haemodynamics and mortality
Measured: Min. 2 years
Health care resource use required to complete BPA
As assessed by total hospital days in/out
Measured: Min. 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start2 Mar 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- International CTEPH Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick H Kim, Prof, Principal investigator, International CTEPH Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245268
- Sponsor's protocol ID
- BPA Registry
- Status last verified
- Jun 2022
- First submitted
- 3 Aug 2017
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lang IM. Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Clinical Outcomes. Eur Cardiol. 2023 Apr 5;18:e11. doi: 10.15420/ecr.2022.29. eCollection 2023.
PubMed 37405334
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International BPA Registry
- ClinicalTrials.gov ID
- NCT03245268
- Acronym / sponsor ID
- BPA Registry
- Keywords
- Balloon pulmonary angioplasty, BPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- International CTEPH AssociationUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 10 Aug 2017 (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.
The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with CTEPH meeting the inclusion criteria listed below and scheduled to undergo BPA intervention are eligible for inclusion into the International BPA Registry.
Key inclusion criteria (7 listed)
- Diagnosis with CTEPH according to the following criteria:
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
- Naïve to BPA treatment
- Scheduled to undergo their first BPA session ≥ 1 day after enrollment. Enrollment is defined as date the consent is signed by the patient. Enrollment must occur before any BPA session
- Willing to provide informed consent
Key exclusion criteria (3 listed)
- BPA treatment prior to enrollment
- Pulmonary hypertension cause other than World Health Organization (WHO) group IV (CTEPH)
- Targeted BPA treatment lesion other than from WHO group IV (CTEPH)
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: BPABPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography. | Procedure or surgery | – |
Primary outcome
Safety as assessed by BPA-associated complications
Time frame: Min. 2 years
Efficacy as assessed by change in PVR
Time frame: Min. 2 years
Change in pulmonary vascular resistance (PVR) from baseline to latest post-interventional follow-up hemodynamics
Efficacy as assessed by change in mPAP
Time frame: Min. 2 years
Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics
11 secondary outcomes
Compare volume of BPA cases across regions and case load at the end of recruitment
Time frame: Min. 2 years
Analyze patient selection criteria for BPA across sites at the end of recruitment
Time frame: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites
Time frame: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals
Time frame: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by number of sessions per patient and follow-up
Time frame: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by number of interventions per patient and follow-up
Time frame: Min. 2 years
At the end of follow-up, compare technical aspects of BPA as assessed by technical limits
Time frame: Min. 2 years
Analyze the use of PH targeted medical therapy before BPA
Time frame: Min. 2 years
Analyze the use of PH targeted medical therapy after BPA
Time frame: Min. 2 years
Analyze the impact of PH targeted medical treatment on key patient outcomes
Time frame: Min. 2 years
Health care resource use required to complete BPA
Time frame: Min. 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 37405334Lang IM. Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Clinical Outcomes. Eur Cardiol. 2023 Apr 5;18:e11. doi: 10.15420/ecr.2022.29. eCollection 2023.
- Website of the International CTEPH AssociationLink provided by the sponsor.
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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.
Nick H Kim, Prof principal investigator
International CTEPH Association
18 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension and CTEPH, run by International CTEPH Association at 18 sites in 10 countries.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Japan, France, Austria, Belgium and 5 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by BPA-associated complications (time frame: Min. 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245268, which also lists 1 linked publication.
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 10 Jun 2022.