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NCT Number: NCT03146754

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

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.

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Key information

Conditions

Acute Decompensated Heart Failure

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19054, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Methodology

Other

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

Primary outcomes

  1. Change in B-line score

    Time frame: Day 1

    Measured by lung ultrasound

  2. Change in B-line score

    Time frame: Day 1

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

  3. Change in B-line score

    Time frame: Day 1

    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)

  4. Change in B-line score

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Acronym: LUPE

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 10, 2017
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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