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

Not Applicable

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Other: Methodology

• Registration Number: NCT03146754
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-04
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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 (β-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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stable ADHF patients	Methodology	Lung ultrasound to access b lines
Control Patients	Methodology	Patients without any cardiopulmonary disease will be control patients for the active subjects, age-matched accordingly.

Primary Outcome Measures

Name	Time	Method
Change in B-line score	Day 1	Change in B-line score with exercise (in those subjects undergoing assessment)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States