Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume

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: Recruiting
• Conditions: Heart Failure; Pulmonary Vascular Disease

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Circulatory Failure Research Team; Phone Number: 507-255-2200
• Study Contact Backup: Name: Barry Borlaug, MD; Phone Number: 507-255-2142; Email: Borlaug.Barry@mayo.edu

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: Barry Borlaug, MD; Phone Number: 507-255-2142; Email: Borlaug.Barry@mayo.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Vascular Capacitance at Rest	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	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

Outcome Measure	Measure Description	Time Frame
Pulmonary Blood Volume at Rest	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Barry Borlaug, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID 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