RV Conductance Catheter Assessment During Balloon Pulmonary Angioplasty (RVBPA)

November 21, 2023 updated by: Papworth Hospital NHS Foundation Trust

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Recruiting
        • Royal Papworth Hospital
        • Contact:
          • Stephen P Hoole
        • Principal Investigator:
          • Stephen P Hoole, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with inoperable CTEPH undergoing BPA

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Invasive RV assessment
RV conductance catheter assessment of RV performance
Procedure: Balloon pulmonary angioplasty
Balloon dilatation of sub segmental pulmonary artery web disease

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in RV Tau
Time Frame: 3 months
Does BPA result in a significant change in right ventricular time constant of diastolic relaxation - a measure of diastolic dysfunction
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ang2 an pro-NT BNP
Time Frame: 3 months
Does Ang2 and pro-NT BNP correlate with invasively acquired pressure volume loop data
3 months
CMR
Time Frame: 3 months
Does non-invasive ventriculo-arterial (VA) coupling by cardiac magnetic resonance imaging correlate with invasively derived pressure volume loop data
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Papworth Hospital NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen P Hoole, MD, Royal Papworth Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 229599

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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