Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume

Heart Failure Clinical Trial

Official title:

Assessment of Pulmonary Blood Volume Using Contrast Echocardiography During Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195059
• Other study ID #: 23-009478
• Status: Recruiting
• Start date: May 2024
• Est. completion date: November 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Circulatory Failure Research Team
• Phone: 507-255-2200
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Pulmonary Vascular Disease
• Vascular Diseases

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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