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

NCT03146754 | Completed

• 1 other identifier: 827232
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (4)

• Change in B-line score

  Measured by lung ultrasound

  Day 1

• Change in B-line score

  Change in B-line score with leg elevation (in those subjects undergoing assessment)

  Day 1

• 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

• Change in B-line score

  Change in B-line score with exercise (in those subjects undergoing assessment)

  Day 1

Study Arms (2)

Stable ADHF patients

EXPERIMENTAL

Lung ultrasound to access b lines

Other: Methodology

Control Patients

ACTIVE COMPARATOR

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

Other: Methodology

Interventions

Methodology OTHER

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

Control Patients; Stable ADHF patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19054, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: May 4, 2017
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)