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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Sarah Fielding, PhD contact

+441223639960

sarah.fielding2@nhs.net

United Kingdom1 site, 1 recruiting
  • Royal Papworth Hospital

    Cambridge

    Stephen P Hoole

    Stephen P Hoole, MD

    Recruiting

Other trials in United Kingdom

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 groups in NCT04444973
Study groupRoleWhat they receive
Invasive RV assessmentRV 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.

  1. 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)
  1. Ang2 an pro-NT BNP

    Does Ang2 and pro-NT BNP correlate with invasively acquired pressure volume loop data

    Measured: 3 months

  2. 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.

  1. First posted24 Jun 2020
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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)
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

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.

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