Clinical trial NCT06195059: Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume
Official title: Assessment of Pulmonary Blood Volume Using Contrast Echocardiography During Exercise
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Pulmonary Vascular Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary Vascular Capacitance at Rest
timeFrame: Baseline
measure: Pulmonary Vascular Capacitance During Exercise
timeFrame: Baseline
Secondary outcomes:
measure: Pulmonary Blood Volume at Rest
timeFrame: Baseline
measure: Pulmonary Blood Volume During Exercise
timeFrame: Baseline
measure: Pulmonary Vascular Compliance at Rest
timeFrame: Baseline
measure: Pulmonary Vascular Compliance During Exercise
timeFrame: Baseline
measure: Right Atrial Pressure at Rest
timeFrame: Baseline
measure: Right Atrial Pressure During Exercise
timeFrame: Baseline
measure: Right Ventricular Pressure at Rest
timeFrame: Baseline
measure: Right Ventricular Pressure During Exercise
timeFrame: Baseline
measure: Pulmonary Artery Pressure at Rest
timeFrame: Baseline
measure: Pulmonary Artery Pressure During Exercise
timeFrame: Baseline
measure: Pulmonary Capillary Wedge Pressure at Rest
timeFrame: Baseline
measure: Pulmonary Capillary Wedge Pressure During Exercise
timeFrame: Baseline
measure: Cardiac Output at Rest
timeFrame: Baseline
measure: Cardiac Output During Exercise
timeFrame: Baseline
measure: Pulmonary Vascular Resistance at Rest
timeFrame: Baseline
measure: Pulmonary Vascular Resistance During Exercise
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barry Borlaug, MD
role: PRINCIPAL_INVESTIGATOR
References: