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RecruitingNCT04444973RVBPAUpdated Nov 22, 2023

RV Conductance Catheter Assessment During Balloon Pulmonary Angioplasty

An observational study in Chronic Thromboembolic Pulmonary Hypertension, sponsored by Papworth Hospital NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Papworth Hospital NHS Foundation Trust · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Thromboembolic Pulmonary Hypertension

Keywords

  • Balloon pulmonary angioplasty
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 20 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Papworth Hospital NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with inoperable CTEPH undergoing BPA

Inclusion criteria

  • >18 years old
  • Able to provide informed consent
  • Inoperable CTEPH eligible for BPA treatment

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Invasive RV assessment

    RV conductance catheter assessment of RV performance

    Procedure: Balloon pulmonary angioplasty

Interventions

  • ProcedureBalloon pulmonary angioplasty

    Balloon dilatation of sub segmental pulmonary artery web disease

06

What researchers measure

Primary outcomes

  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

    Time frame: 3 months

Secondary outcomes

  1. Ang2 an pro-NT BNP

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

    Time frame: 3 months

  2. CMR

    Does non-invasive ventriculo-arterial (VA) coupling by cardiac magnetic resonance imaging correlate with invasively derived pressure volume loop data

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Royal Papworth Hospital
    Cambridge, United Kingdom
    • Stephen P Hoole · Contact
    • Stephen P Hoole, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD data will not be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04444973
Lead sponsor
Papworth Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
Jun 24, 2020
Start date
Jan 1, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 22, 2023

Study contacts

Sarah Fielding, PhD
Contact
sarah.fielding2@nhs.net
+441223639960
Stephen P Hoole, MD
principal investigator · Royal Papworth Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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