Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume

August 18, 2026 updated by: Barry Borlaug, Mayo Clinic

Assessment of Pulmonary Blood Volume Using Contrast Echocardiography During Exercise

The purpose of this study is to evaluate whether pulmonary blood volume (PBV) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (PAWP) during exercise. Also, to compare changes in PBV with exercise in patients with and without heart failure and pulmonary vascular disease.

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.

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.
800

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.
  • Name: Circulatory Failure Research Team
  • Phone Number: 507-255-2200

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Barry Borlaug, MD
        • Contact:
          • Circulatory Failure Research Team
          • Phone Number: 507-255-2200
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who have already been referred to the catheterization laboratory at Mayo Clinic in Rochester, MN for the exercise hemodynamic assessment will be enrolled in this study.

Description

Inclusion Criteria:

  • Patients referred to the cardiac catheterization laboratory for invasive exercise right heart catheterization for evaluating exertional dyspnea. Investigators will include patients with normal or low EF, and across the spectrum of pulmonary hypertension severity.

Exclusion Criteria:

  • Patient inability or unwillingness to undergo echocardiography including a contrast method, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.
  • Prior adverse reaction to echo contrast administration

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

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
Pulmonary Vascular Capacitance at Rest
Time Frame: Baseline
Capacitance is defined as the total volume of blood in an organ or region at a given pressure. Pulmonary Vascular Capacitance (ml/mmHg) will be determined by pulmonary blood volume/mean pulmonary artery pressure as measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Vascular Capacitance During Exercise
Time Frame: Baseline
Capacitance is defined as the total volume of blood in an organ or region at a given pressure. Pulmonary Vascular Capacitance (ml/mmHg) will be determined by pulmonary blood volume/mean pulmonary artery pressure as measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline

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
Pulmonary Blood Volume at Rest
Time Frame: Baseline
Pulmonary blood volume (ml) is measured by measuring indicator dilution curves using sonographic contrast at rest during the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Blood Volume During Exercise
Time Frame: Baseline
Pulmonary blood volume (ml) is measured by measuring indicator dilution curves using sonographic contrast during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Vascular Compliance at Rest
Time Frame: Baseline
Compliance is the change in volume for a given change in pressure. Pulmonary Vascular Compliance (ml/mmHg) is defined as stroke volume divided by Pulmonary Artery (PA) pulse pressure and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Vascular Compliance During Exercise
Time Frame: Baseline
Compliance is the change in volume for a given change in pressure. Pulmonary Vascular Compliance (ml/mmHg) is defined as stroke volume divided by Pulmonary Artery (PA) pulse pressure and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline
Right Atrial Pressure at Rest
Time Frame: Baseline
Right Atrial Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.
Baseline
Right Atrial Pressure During Exercise
Time Frame: Baseline
Right Atrial Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline
Right Ventricular Pressure at Rest
Time Frame: Baseline
Right Ventricular Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.
Baseline
Right Ventricular Pressure During Exercise
Time Frame: Baseline
Right Ventricular Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Artery Pressure at Rest
Time Frame: Baseline
Pulmonary Artery Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Artery Pressure During Exercise
Time Frame: Baseline
Pulmonary Artery Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Capillary Wedge Pressure at Rest
Time Frame: Baseline
Pulmonary capillary wedge pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Capillary Wedge Pressure During Exercise
Time Frame: Baseline
Pulmonary capillary wedge pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline
Cardiac Output at Rest
Time Frame: Baseline
Cardiac output (L/min) is the total volume of blood moved by the heart per minute and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.
Baseline
Cardiac Output During Exercise
Time Frame: Baseline
Cardiac output (L/min) is the total volume of blood moved by the heart per minute and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Vascular Resistance at Rest
Time Frame: Baseline
Pulmonary vascular resistance (PVR) is the resistance against blood flow from the pulmonary artery to the left atrium. PVR (in Wood units) will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.
Baseline
Pulmonary Vascular Resistance During Exercise
Time Frame: Baseline
Pulmonary vascular resistance (PVR) is the resistance against blood flow from the pulmonary artery to the left atrium. PVR (in Wood units) will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.
Baseline

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.
Mayo Clinic

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: Barry Borlaug, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
July 30, 2024

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.
August 1, 2027

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.
August 1, 2027

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).
December 19, 2023

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.
January 5, 2024

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.
January 8, 2024

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.
August 20, 2026

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.
August 18, 2026

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.
August 1, 2026

More Information

Terms related to this study

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.
  • 23-009478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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