Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing

NCT04019613 | Terminated Results FDA Device

• 1 other identifier: 19-002499
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea; Heart Failure With Preserved Ejection Fraction

Keywords

dyspnea; heart failure with preserved ejection fraction; pulmonary edema; lung ultrasound; extravascular lung water

Outcome Measures

Primary Outcomes (1)

• Correlation of the Number of Lung Ultrasound B-Lines With Intra-cardiac Filling Pressures

  Lung ultrasound will be performed during invasive stress testing. The number of B-lines visible during stress testing will be correlated with synchronous measurements of 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 Outcomes (4)

• 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.

Study Arms (1)

Subjects undergoing clinical invasive hemodynamic stress test

EXPERIMENTAL

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.

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasound DIAGNOSTIC_TEST

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.

Also known as: Pulmonary Thermodilution

Subjects undergoing clinical invasive hemodynamic stress test

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients with known interstitial lung disease or pulmonary fibrosis

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Dyspnea; Pulmonary Edema

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases

Results Point of Contact

• Title: Dr. Brandon M. Wiley
• Organization: Mayo Clinic

Wiley.Brandon@mayo.edu

507-255-1051

Study Officials

• Barry Borlaug, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 15, 2019
• Study Start: November 8, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: July 20, 2022
• Results First Posted: July 20, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)