Clinical trial NCT04019613: Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing
Official title: Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyspnea
Heart Failure With Preserved Ejection Fraction
Keywords: dyspnea
heart failure with preserved ejection fraction
pulmonary edema
lung ultrasound
extravascular lung water
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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)).

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

Primary outcomes:
measure: Correlation of the Number of Lung Ultrasound B-Lines With Intra-cardiac Filling Pressures
timeFrame: 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 outcomes:
measure: Correlation of the Number of Lung Ultrasound B-Lines With Ventilatory Mechanics.
timeFrame: 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).
measure: Correlation of the Number of Lung Ultrasound B-Lines Developed During Invasive Stress Testing With Measurement of Extravascular Lung Water.
timeFrame: 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).
measure: 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.
timeFrame: Serum biomarkers, lung ultrasound and assessment of extravascular lung water will be performed during the scheduled invasive stress test (initial visit, day #1).
measure: Correlation of the Number of Lung Ultrasound B-Lines Developed During Invasive Stress Testing With Clinical Outcomes.
timeFrame: 24 months post-stress test.
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: