RV Conductance Catheter Assessment During Balloon Pulmonary Angioplasty
NCT ID: NCT04444973
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
20 participants
OBSERVATIONAL
2022-01-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Invasive RV assessment
RV conductance catheter assessment of RV performance
Balloon pulmonary angioplasty
Balloon dilatation of sub segmental pulmonary artery web disease
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Balloon pulmonary angioplasty
Balloon dilatation of sub segmental pulmonary artery web disease
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to provide informed consent
* Inoperable CTEPH eligible for BPA treatment
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Papworth Hospital NHS Foundation Trust
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephen P Hoole, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Papworth Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Papworth Hospital
Cambridge, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stephen P Hoole
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
229599
Identifier Type: -
Identifier Source: org_study_id