Chronic Thromboembolic Pulmonary HypertensionRVBPANCT04444973
RV Conductance Catheter Assessment During Balloon Pulmonary Angioplasty
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Balloon pulmonary angioplasty (BPA) treats patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). Intra-procedural markers of success to guide the intervention are lacking. 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
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2022to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with inoperable CTEPH undergoing BPA
Who may be able to join
- >18 years old
- Able to provide informed consent
- Inoperable CTEPH eligible for BPA treatment
Who cannot join
- Severe co-morbidity (expected life <6months)
- Women of child bearing age
- Significant known left to right shunt
- Permanent pacemaker
- Atrial fibrillation
- Severe lung parenchyma disease ( eg emphysema, Interstitial Lung Disease (ILD)).
- Retained metallic foreign body
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Papworth Hospital
Cambridge
Stephen P Hoole
Stephen P Hoole, MD
About this study
Official title: Use of Right Ventricular Conductance Catheter Guidance to Optimise Balloon Pulmonary Angioplasty as a Non Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension.
Balloon pulmonary angioplasty (BPA) treats patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). Intra-procedural markers of success to guide the intervention are lacking. The investigators propose to measure right ventricular (RV) pressure volume loops invasively and measure biomarkers at intervals during the course of a course of BPA. These data will be analysed to define load independent indices of RV functional improvement, cross correlated with biomarker data and be used to calibrate non-invasive assessment of ventriculo-arterial coupling by cardiac magnetic resonance imaging (CMR) to better detect responders of BPA and pulmonary endarterectomy (PEA).
Read the detailed description
Patients who have Chronic Thromboembolic Pulmonary Hypertension (CTEPH) can treated surgically or by undergoing minimally invasive balloon pulmonary angioplasty (BPA). However not all patients have resolution of their pulmonary hypertension following these procedures, and some patients who don't have pulmonary hypertension derive substantial benefit nonetheless from surgical clearance of their thromboembolic disease.
Thus better understanding of the interaction between the blood vessels, the right heart workload, and symptoms and outcomes is required to predict treatment response. Ventriculo-arterial coupling is one such measure, quantifying the efficiency of transfer of energy from the right ventricle to the pulmonary arteries. Traditionally this has required invasive procedures involving intracavity conduction catheterisation of the right ventricle to simultaneously measure flow and pressure whilst altering preload. Not only is this invasive, but it is not routinely performed in clinical practice due to its complexity and requirement for specialised expertise and equipment. As CMR can simultaneously assess right ventricular and pulmonary function it may be able to assess function and ventriculo-arterial coupling non-invasively and allow for a more detailed and accessible mode of disease quantification and stratification.
The investigators will measure how the right heart function changes during BPA in patients with inoperable CTEPH, measured using a conductance catheter placed within the pumping chamber on the right side of the heart (right ventricle). This will generate pressure volume loops to detect intra-procedural changes of ventriculo-arterial coupling that can be used to quantify treatment success. The investigators will also monitor the levels of a newly discovered vessel inflammatory marker in the blood - Angiopoietin 2 (Ang2), and N-terminal pro-brain natriuretic peptide (NT-Pro BNP) that may also be useful in identifying responders to treatment and help define the optimal treatment protocol for BPA.
This participants will have CMR as standard of care. Data from CMR and invasive measurements of ventriculo-arterial coupling will determine the best CMR measures of coupling efficiency. These measures will then be applied within a large well-characterised cohort with long term follow-up to determine its association with symptoms, and outcomes following surgical intervention.
- Being tested
- Balloon pulmonary angioplasty
- Keywords
- 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
Balloon dilatation of sub segmental pulmonary artery web disease
| Study group | Role | What they receive |
|---|---|---|
| Invasive RV assessment | RV conductance catheter assessment of RV performance Receives: Procedure: Balloon pulmonary angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RV Tau
Does BPA result in a significant change in right ventricular time constant of diastolic relaxation - a measure of diastolic dysfunction
Measured: 3 months
Secondary outcomes (2)
Ang2 an pro-NT BNP
Does Ang2 and pro-NT BNP correlate with invasively acquired pressure volume loop data
Measured: 3 months
CMR
Does non-invasive ventriculo-arterial (VA) coupling by cardiac magnetic resonance imaging correlate with invasively derived pressure volume loop data
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stephen P Hoole, MD, Principal investigator, Royal Papworth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444973
- Sponsor's protocol ID
- 229599
- Acronym
- RVBPA
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Right Ventricular Conductance Catheter Guidance to Optimise Balloon Pulmonary Angioplasty as a Non Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT04444973
- Acronym / sponsor ID
- RVBPA / 229599
- Keywords
- Balloon pulmonary angioplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jun 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.
Balloon pulmonary angioplasty (BPA) treats patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). Intra-procedural markers of success to guide the intervention are lacking. The investigators propose to measure right ventricular (RV) pressure volume loops invasively and measure biomarkers at intervals during the course of a course of BPA. These data will be analysed to define load independent indices of RV functional improvement, cross correlated with biomarker data and be used to calibrate non-invasive assessment of ventriculo-arterial coupling by cardiac magnetic resonance imaging (CMR) to better detect responders of BPA and pulmonary endarterectomy (PEA).
Detailed description
Patients who have Chronic Thromboembolic Pulmonary Hypertension (CTEPH) can treated surgically or by undergoing minimally invasive balloon pulmonary angioplasty (BPA). However not all patients have resolution of their pulmonary hypertension following these procedures, and some patients who don't have pulmonary hypertension derive substantial benefit nonetheless from surgical clearance of their thromboembolic disease.
Thus better understanding of the interaction between the blood vessels, the right heart workload, and symptoms and outcomes is required to predict treatment response. Ventriculo-arterial coupling is one such measure, quantifying the efficiency of transfer of energy from the right ventricle to the pulmonary arteries. Traditionally this has required invasive procedures involving intracavity conduction catheterisation of the right ventricle to simultaneously measure flow and pressure whilst altering preload. Not only is this invasive, but it is not routinely performed in clinical practice due to its complexity and requirement for specialised expertise and equipment. As CMR can simultaneously assess right ventricular and pulmonary function it may be able to assess function and ventriculo-arterial coupling non-invasively and allow for a more detailed and accessible mode of disease quantification and stratification.
The investigators will measure how the right heart function changes during BPA in patients with inoperable CTEPH, measured using a conductance catheter placed within the pumping chamber on the right side of the heart (right ventricle). This will generate pressure volume loops to detect intra-procedural changes of ventriculo-arterial coupling that can be used to quantify treatment success. The investigators will also monitor the levels of a newly discovered vessel inflammatory marker in the blood - Angiopoietin 2 (Ang2), and N-terminal pro-brain natriuretic peptide (NT-Pro BNP) that may also be useful in identifying responders to treatment and help define the optimal treatment protocol for BPA.
This participants will have CMR as standard of care. Data from CMR and invasive measurements of ventriculo-arterial coupling will determine the best CMR measures of coupling efficiency. These measures will then be applied within a large well-characterised cohort with long term follow-up to determine its association with symptoms, and outcomes following surgical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive RV assessment | – | Procedure: Balloon pulmonary angioplastyRV conductance catheter assessment of RV performance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inoperable CTEPH undergoing BPA
Key inclusion criteria (3 listed)
- >18 years old
- Able to provide informed consent
- Inoperable CTEPH eligible for BPA treatment
Key exclusion criteria (7 listed)
- Severe co-morbidity (expected life <6months)
- Women of child bearing age
- Significant known left to right shunt
- Permanent pacemaker
- Atrial fibrillation
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 angioplastyBalloon dilatation of sub segmental pulmonary artery web disease | Procedure or surgery | Invasive RV assessment |
Primary outcome
Change in RV Tau
Time frame: 3 months
Does BPA result in a significant change in right ventricular time constant of diastolic relaxation - a measure of diastolic dysfunction
2 secondary outcomes
Ang2 an pro-NT BNP
Time frame: 3 months
CMR
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. IPD data will not be shared
Related trials for Chronic Thromboembolic Pulmonary Hypertension
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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.
Stephen P Hoole, MD principal investigator
Royal Papworth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 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 Nov 2023. 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 United Kingdom. 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 Sarah Fielding, PhD (+441223639960, sarah.fielding2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in RV Tau (time frame: 3 months). 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 Nov 2023.