A Study to Evaluate Lung Ultrasound as a Method to Measure Changes in Extravascular Lung Water Induced by Positional Changes (LUPE)
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/21/2018 |
| Start Date: | May 4, 2017 |
| End Date: | November 2019 |
| Contact: | kimberly clinton |
| Email: | kimberly.clinton@uphs.upenn.edu |
| Phone: | 215-662-2803 |
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
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.
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.
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)
We found this trial at
2
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Kenneth Margulies, MD
Phone: 215-662-2803
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Rochester, Minnesota 55905
Principal Investigator: Suraj Kapa, MD
Phone: 507-293-2762
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