RV Conductance Catheter Assessment During Balloon Pulmonary Angioplasty
RVBPA
Use of Right Ventricular Conductance Catheter Guidance to Optimise Balloon Pulmonary Angioplasty as a Non Surgical Treatment of Chronic Thromboembolic Pulmonary Hypertension.
1 other identifier
observational
20
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 22, 2023
November 1, 2023
3 years
June 21, 2020
November 21, 2023
Conditions
Keywords
Outcome Measures
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
3 months
Secondary Outcomes (2)
Ang2 an pro-NT BNP
3 months
CMR
3 months
Study Arms (1)
Invasive RV assessment
RV conductance catheter assessment of RV performance
Interventions
Balloon dilatation of sub segmental pulmonary artery web disease
Eligibility Criteria
Patients with inoperable CTEPH undergoing BPA
You may qualify if:
- \>18 years old
- Able to provide informed consent
- Inoperable CTEPH eligible for BPA treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Papworth Hospital
Cambridge, United Kingdom
Biospecimen
Venous blood
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen P Hoole, MD
Royal Papworth Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2020
First Posted
June 24, 2020
Study Start
January 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
IPD data will not be shared