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

NCT ID: NCT03146754

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2023-01-01

Brief Summary

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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

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Conditions

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Acute Decompensated Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Stable ADHF patients

Lung ultrasound to access b lines

Group Type EXPERIMENTAL

Methodology

Intervention Type OTHER

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

Control Patients

Patients without any cardiopulmonary disease will be control patients for the active subjects, age-matched accordingly.

Group Type ACTIVE_COMPARATOR

Methodology

Intervention Type OTHER

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

Interventions

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Methodology

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

Intervention Type OTHER

Eligibility Criteria

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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 (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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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827232

Identifier Type: -

Identifier Source: org_study_id