Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume

NCT06195059 | Recruiting

• 1 other identifier: 23-009478
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Pulmonary Vascular Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Pulmonary Blood Volume at Rest

  Baseline

• Pulmonary Blood Volume During Exercise

  Baseline

• Pulmonary Vascular Compliance at Rest

  Baseline

• Pulmonary Vascular Compliance During Exercise

  Baseline

• Right Atrial Pressure at Rest

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Barry Borlaug, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Circulatory Failure Research Team

CONTACT

507-255-2200

Barry Borlaug, MD

CONTACT

507-255-2142; Borlaug.Barry@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 8, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)