RV Conductance Catheter Assessment During Balloon Pulmonary Angioplasty

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

— RVBPA  

Official title:

Use of Right Ventricular Conductance Catheter Guidance to Optimise Balloon Pulmonary Angioplasty as a Non Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04444973
• Other study ID #: 229599
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Papworth Hospital NHS Foundation Trust
• Contact: Sarah Fielding, PhD
• Phone: +441223639960
• Email: sarah.fielding2[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• Able to provide informed consent

• Inoperable CTEPH eligible for BPA treatment

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Procedure:
• Balloon pulmonary angioplasty
Balloon dilatation of sub segmental pulmonary artery web disease

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in RV Tau	Does BPA result in a significant change in right ventricular time constant of diastolic relaxation - a measure of diastolic dysfunction	3 months
Secondary	Ang2 an pro-NT BNP	Does Ang2 and pro-NT BNP correlate with invasively acquired pressure volume loop data	3 months
Secondary	CMR	Does non-invasive ventriculo-arterial (VA) coupling by cardiac magnetic resonance imaging correlate with invasively derived pressure volume loop data	3 months