Chronic Thromboembolic Pulmonary HypertensionEXPERT-BPANCT04052243
Hemodynamic Effects of BPA at Rest and During Exercise in CTEPH
A study testing Invasive exercise testing in people with Chronic Thromboembolic Pulmonary Hypertension, run by Aarhus University Hospital at 3 sites in 3 countries.
Trial summary
Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right heart failure. 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?
- Invasive exercise testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jan 2021to 30 Jun 2024
- 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
- -Patients with CTEPH or CTED eligible for balloon pulmonary angioplasty.
Who cannot join
- -Patients unable to perform ergometer exercise
Trial locations and contacts
3 sites in 3 countries.
Jens Erik Nielsen-Kudsk, MD, Dm.Sci. contact
3 sites in 3 countries
Denmark1 site, 1 recruiting
- Recruiting
Department of cardiology, Aarhus University Hospital
Aarhus, 8200
Mads J Andersen, MD, PhD, +4578450000, madsae@rm.dk
Jens Erik Nielsen-Kudsk, MD, Dm.Sci
Japan1 site, 1 recruiting
- Not yet recruiting
Nagoya University Hospital
Nagoya
Shiro Adachi, PhD
Shiro Adachi
Poland1 site, 1 recruiting
- Recruiting
European Health Center
Otwock
Szymon Darocha, PhD
Szymon Darocha
About this study
Official title: An International Multicenter Observational Study to Assess the Hemodynamic Effects of Balloon Pulmonary Angioplasty (BPA) at Rest and During Exercise in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or Chronic Thromboembolic Pulmonary Disease (CTED) Patients (EXPERT-BPA)
Chronic thromboembolic pulmonary hypertension (CTEPH) is characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right heart failure.
Medical therapy and balloon angioplasty (BPA) are effective treatment alternatives in lowering pulmonary pressures and increasing pulmonary flow.
The aim of this study is to assess the hemodynamic effects of BPA or medical therapy on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance.
Read the detailed description
Chronic thromboembolic pulmonary hypertension [CTEPH] is a rare condition with a significant risk of morbidity and mortality. The primary cause of CTEPH is thrombotic lesions, which did not resolve after acute pulmonary embolism. This causes increased pulmonary vascular resistance [PVR], leading to secondary remodeling of pulmonary arteries causing pulmonary hypertension and ultimately progressive right heart failure. The treatment of choice is surgical pulmonary endarterectomy [PEA], however up to 40% cases are not treated surgically, due to operability, anatomic location of the lesions, patient choice and comorbidities significantly increasing procedural risk. A new alternative procedure, balloon pulmonary angioplasty [BPA] has been proposed for patients with inoperable CTEPH or persistent pulmonary hypertension after pulmonary endarterectomy (PEA) and is currently characterized with good outcome in functional capacity, hemodynamic parameters, biomarkers, and health-related quality of life.
Exercise stress tests of the pulmonary circulation are used in workup and diagnosis of pulmonary hypertension as a hemodynamic abnormality. The approach has allowed identification of patients with normal or marginally increased mPAP at rest but with symptomatic increases in mPAP at exercise, related to either increased resistance or increased left atrial pressure. Although this differential diagnosis is of obvious therapeutic relevance, guidelines about exercise stress studies of the pulmonary circulation have not been developed until now for lack of robust evidence allowing for a consensus on clearly defined cutoff values.
Neither the pathophysiology of the exercise limitation nor the underlying mechanisms of the BPA - induced improvement were studied before. Therefore the aim of this study is to assess the hemodynamic effects of BPA treatment on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance. Furthermore, the investigators will explore possible differences in treatment effect across centers. Especially explore the timing of medical therapy vs balloon angioplasty.
.
- Being tested
- Invasive exercise testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive exercise testingDiagnostic test
Invasive hemodynamic exercise testing
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Exercise is added to resting right heart catheterization Receives: Diagnostic Test: Invasive exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of mPA/CO after BPA
Change from Baseline in Slope of mean pulmonary artery pressure/cardiac output after BPA at 6 months
Measured: 6 months after last BPA session
Secondary outcomes (3)
Change in resting PVR after BPA
Change from Baseline in pulmonary vascular resistance (PVR) after BPA at 6 months
Measured: 6 months after last BPA session
Change in 6 MWT after BPA
Change from Baseline in 6 minute walk test (MWT) after BPA at 6 months
Measured: 6 months after last BPA session
Change in NT-proBNP after BPA
Change from Baseline in NT-proBNP after BPA at 6 months
Measured: 6 months after last BPA session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exercise is added to the resting right heart catheterization.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nagoya University, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
- Responsible party
- Principal investigator, Mads Jønsson Andersen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052243
- Sponsor's protocol ID
- EXPERT-BPA
- Acronym
- EXPERT-BPA
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter Observational Study to Assess the Hemodynamic Effects of Balloon Pulmonary Angioplasty (BPA) at Rest and During Exercise in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or Chronic Thromboembolic Pulmonary Disease (CTED) Patients (EXPERT-BPA)
- ClinicalTrials.gov ID
- NCT04052243
- Acronym / sponsor ID
- EXPERT-BPA / EXPERT-BPA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Nagoya University, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 9 Aug 2019 (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 characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right heart failure.
Medical therapy and balloon angioplasty (BPA) are effective treatment alternatives in lowering pulmonary pressures and increasing pulmonary flow.
The aim of this study is to assess the hemodynamic effects of BPA or medical therapy on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance.
Detailed description
Chronic thromboembolic pulmonary hypertension [CTEPH] is a rare condition with a significant risk of morbidity and mortality. The primary cause of CTEPH is thrombotic lesions, which did not resolve after acute pulmonary embolism. This causes increased pulmonary vascular resistance [PVR], leading to secondary remodeling of pulmonary arteries causing pulmonary hypertension and ultimately progressive right heart failure. The treatment of choice is surgical pulmonary endarterectomy [PEA], however up to 40% cases are not treated surgically, due to operability, anatomic location of the lesions, patient choice and comorbidities significantly increasing procedural risk. A new alternative procedure, balloon pulmonary angioplasty [BPA] has been proposed for patients with inoperable CTEPH or persistent pulmonary hypertension after pulmonary endarterectomy (PEA) and is currently characterized with good outcome in functional capacity, hemodynamic parameters, biomarkers, and health-related quality of life.
Exercise stress tests of the pulmonary circulation are used in workup and diagnosis of pulmonary hypertension as a hemodynamic abnormality. The approach has allowed identification of patients with normal or marginally increased mPAP at rest but with symptomatic increases in mPAP at exercise, related to either increased resistance or increased left atrial pressure. Although this differential diagnosis is of obvious therapeutic relevance, guidelines about exercise stress studies of the pulmonary circulation have not been developed until now for lack of robust evidence allowing for a consensus on clearly defined cutoff values.
Neither the pathophysiology of the exercise limitation nor the underlying mechanisms of the BPA - induced improvement were studied before. Therefore the aim of this study is to assess the hemodynamic effects of BPA treatment on the pressure-flow relationship in the pulmonary vasculature and the pulmonary vascular compliance. Furthermore, the investigators will explore possible differences in treatment effect across centers. Especially explore the timing of medical therapy vs balloon angioplasty.
.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exercise is added to the resting right heart catheterization.
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Diagnostic Test: Invasive exercise testingExercise is added to resting right heart catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients with CTEPH or CTED eligible for balloon pulmonary angioplasty.
Key exclusion criteria (1 listed)
- -Patients unable to perform ergometer exercise
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 |
|---|---|---|
| Invasive exercise testingInvasive hemodynamic exercise testing | Diagnostic test | All patients |
Primary outcome
Slope of mPA/CO after BPA
Time frame: 6 months after last BPA session
Change from Baseline in Slope of mean pulmonary artery pressure/cardiac output after BPA at 6 months
3 secondary outcomes
Change in resting PVR after BPA
Time frame: 6 months after last BPA session
Change in 6 MWT after BPA
Time frame: 6 months after last BPA session
Change in NT-proBNP after BPA
Time frame: 6 months after last BPA session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- 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.
Jens Erik Nielsen-Kudsk, MD, Dm.Sci. contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive exercise testing in people with Chronic Thromboembolic Pulmonary Hypertension, run by Aarhus University Hospital at 3 sites in 3 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 1 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Japan, 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 Mads J Andersen, MD, PhD (+45784500000, madsae@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope of mPA/CO after BPA (time frame: 6 months after last BPA session). 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 20 Jul 2022.