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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) (LUPE)

Primary Purpose

Acute Decompensated Heart Failure

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Methodology

About this trial

This is an interventional basic science trial for Acute Decompensated Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stable ADHF patients

Control Patients

Arm Description

Lung ultrasound to access b lines

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

Outcomes

Primary Outcome Measures

Change in B-line score

Measured by lung ultrasound

Change in B-line score

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

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)

Change in B-line score

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03146754

First Posted

May 8, 2017

Last Updated

December 1, 2022

Sponsor

University of Pennsylvania

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT03146754

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 4, 2017 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Decompensated Heart Failure

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stable ADHF patients

Arm Type

Experimental

Arm Description

Lung ultrasound to access b lines

Arm Title

Control Patients

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Methodology

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in B-line score

Description

Measured by lung ultrasound

Time Frame

Day 1

Title

Change in B-line score

Description

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

Time Frame

Day 1

Title

Change in B-line score

Description

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)

Time Frame

Day 1

Title

Change in B-line score

Description

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

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19054

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De identified IPD will be shared with collaborators

Learn more about this trial

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

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