A Study to Evaluate Lung Ultrasound as a Method to Measure Changes in Extravascular Lung Water Induced by Positional Changes (LUPE)

Acute Decompensated Heart Failure Clinical Trial

— LUPE  

Official title:

A Study to Evaluate Lung Ultrasound as a Method to Measure Changes in Extravascular Lung Water Induced by Positional Changes or Exercise in Patients Stabilized Following Hospitalization for Acute Decompensated Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146754
• Other study ID #: 827232
• Status: Completed
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an exploratory study to evaluate lung ultrasound as a method for measuring extravascular lung water in stabilized patients during hospitalization for ADHF. Subjects who have been stabilized following admission for ADHF and capable of lying supine will be evaluated by lung ultrasound to determine the degree of lung congestion as measured by the total B-line score. Since different patients may require different degrees of postural change and/or other maneuvers (e.g., leg elevation or exercise) to induce B-line increments, a tailored sequential protocol will be employed to define which maneuvers are sufficient for each patient. Control patients, age-matched, will be recruited to provide a comparison group for data analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Hospitalized for the management of acute decompensated heart failure

Reached at least a 12-hour period after hospital admission

Presence of peripheral edema with a score of at least 1+ (slight pitting in both ankles; 2mm or less depression that disappears rapidly)

Able to lie supine with no more than one pillow (approximately a 10 cm head elevation) without dyspnea for at least 30 minutes by patient report

Have not received treatment with any intravenous loop diuretic within the 4 hours prior to initiating study assessments and with no plans for additional intravenous treatment during the series of lung ultrasound measurements

Exclusion Criteria:

Persistent uncontrolled hypertension (resting systolic blood pressure > 160 mmHg)

Significant lung disease including severe chronic obstructive pulmonary disease (See concomitant medication exclusions), pulmonary fibrosis, active asthma or acute pneumonia

Use of medications specified for the treatment of COPD including short- and long-acting bronchodilators (ß-agonists and anticholinergics) and inhaled glucocorticoids as well as oxygen therapy

Use of another investigational product in a clinical study within the following time period prior to the first administration of study medication: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Other:
• Methodology
No intervention will be performed. Study is designed to test methodology of lung ultrasound in accessing b lines (2 phases)

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in B-line score	Measured by lung ultrasound	Day 1
Primary	Change in B-line score	Change in B-line score with leg elevation (in those subjects undergoing assessment)	Day 1
Primary	Change in B-line score	Change in B-line score with the transition to a Trendelenberg position where the head is 10 degrees lower than the feet (in those subjects undergoing assessment)	Day 1
Primary	Change in B-line score	Change in B-line score with exercise (in those subjects undergoing assessment)	Day 1