An interventional study of Methodology in Acute Decompensated Heart Failure, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Basic science
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 15 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Lung ultrasound to access b lines
Other: Methodology
Patients without any cardiopulmonary disease will be control patients for the active subjects, age-matched accordingly.
Other: Methodology
No intervention will be performed. Study is designed to test methodology of lung ultrasound in accessing b lines (2 phases)
Change in B-line score
Measured by lung ultrasound
Time frame: Day 1
Change in B-line score
Change in B-line score with leg elevation (in those subjects undergoing assessment)
Time frame: 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)
Time frame: Day 1
Change in B-line score
Change in B-line score with exercise (in those subjects undergoing assessment)
Time frame: Day 1
Plan to share: Yes — De identified IPD will be shared with collaborators
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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