Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing

Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing

Sponsors

Lead Sponsor: Mayo Clinic

Source Mayo Clinic
Brief Summary

The aim of this study is to utilize lung ultrasound to detect the development of extravascular lung water in patients undergoing clinically indicated invasive hemodynamic exercise stress testing for symptomatic shortness of breath. The study will correlate the lung ultrasound findings with cardiac hemodynamics and measurements of extravascular lung water in an effort to better understand the pathophysiology of exertional dyspnea.

Detailed Description

Exercise induced elevation of left ventricular (LV) filling pressures can be the source of chronic dyspnea. Ultimately, high LV filling pressure leads to the development of extravascular lung water (EVLW) which can cause symptoms of dyspnea. Lung ultrasound (LUS) is a highly feasible, non-invasive procedure that is extremely sensitive for detecting EVLW. The sonographic signature of EVLW is a reverberation artifact called a "B-Line". The study will evaluate the etiology of sonographic B-Lines using invasive hemodynamic catheterization while simultaneously measuring the amount of EVLW present during exercise stress testing using transpulmonary thermodilution. The study aim is to demonstrate that the severity of EVLW, assessed by number of B-Lines, will correlate with LV filling pressures. In addition, the study will test the hypothesis that patients demonstrating dynamic increases in sonographic B-Lines with exercise will also display more severe symptoms of dyspnea, altered ventilatory mechanics (higher ratio of minute ventilation to carbon dioxide production (VE/VCO2)), and reduced aerobic capacity (lower peak oxygen consumption (VO2)).

Overall Status Active, not recruiting
Start Date November 1, 2019
Completion Date November 2022
Primary Completion Date October 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Correlation of the number of lung ultrasound B-Lines with Intra-cardiac Filling Pressures Lung ultrasound imaging for B-Lines and assessment of intracardiac hemodynamics will be performed during the scheduled invasive stress test (initial visit, day #1).
Secondary Outcome
Measure Time Frame
Correlation of the number of lung ultrasound B-Lines with ventilatory mechanics. Lung ultrasound imaging and assessment of ventilatory mechanics (using analysis of expired gas) will be performed during the scheduled invasive stress test (initial visit, day #1).
Correlation of the number of lung ultrasound B-Lines developed during invasive stress testing with measurement of extravascular lung water. Lung ultrasound imaging and assessment of the amount of extravascular lung water using transpulmonary thermodilution will be performed during the scheduled invasive stress test (initial visit, day #1).
Lung ultrasound B-Lines developed during invasive stress and the calculated amount of extravascular lung water will be correlated with changes in the levels of serum protein, hemoglobin and brain natriuretic peptide levels. Serum biomarkers, lung ultrasound and assessment of extravascular lung water will be performed during the scheduled invasive stress test (initial visit, day #1).
Correlation of the number of lung ultrasound B-Lines developed during invasive stress testing with clinical outcomes. 24 months post-stress test.
Enrollment 60
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Lung ultrasound

Description: Lung ultrasound will be performed at baseline (resting), prior to exercise with passive leg elevation, after 1.5 minutes of 20 Watts exercise, during each subsequent stage, at peak workload and at 1 minute recovery. Pulmonary thermodilution will be performed at rest, peak stress and at 1 minute recovery.

Arm Group Label: Subjects undergoing clinical invasive hemodynamic stress test

Other Name: Pulmonary Thermodilution

Eligibility

Criteria:

Inclusion Criteria:

- All adult patients (≥18 years) who are referred for invasive cardiac hemodynamic assessment

- Patients who have the capacity to understand and consent for the research study

Exclusion Criteria:

- Patients with known interstitial lung disease or pulmonary fibrosis

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Mayo Clinic in Rochester
Location Countries

United States

Verification Date

February 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mayo Clinic

Investigator Full Name: Barry Borlaug

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Subjects undergoing clinical invasive hemodynamic stress test

Type: Experimental

Description: Subjects scheduled for standard-of-care, clinically indicated, invasive hemodynamic stress test will undergo lung ultrasound and assessment of extravascular lung water by pulmonary thermodilution technique.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: All patients undergoing a clinically indicated invasive cardiac hemodynamic exercise test will be eligible for enrollment into the study.

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov