Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF (GALLANT)
This is a multi-center prospective pilot clinical study to assess the utility of the Triage NGAL Test - alone and in conjunction with the Triage BNP test - as an aid in the early risk assessment for heart-failure-related adverse clinical outcomes (deaths, readmissions, and additional emergent outpatient visits) through Day 30 and Day 90 in patients presenting with acutely decompensated heart failure (HF). Its utility as an aid in the early risk assessment for renal dysfunction in patients with acutely decompensated heart failure undergoing treatment with IV diuretics will also be assessed.
Acute Decompensated Heart Failure
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||NGAL Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF|
|Study Start Date:||September 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Approximately 200 adults presenting to the Emergency Department (ED) / hospital with acutely decompensated HF will be enrolled. EDTA anti-coagulated blood samples will be collected for measurement of blood NGAL levels (using the Triage NGAL Test) at the point of care in all subjects at up to 8 different time points from presentation until discharge.
The results of these NGAL assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.
Blood samples for unblinded assessment of both serum creatinine (analyzed at the hospital's laboratory) and whole blood BNP (analyzed with the Triage BNP Test at the point-of-care or laboratory) will also be obtained at some of the same time points.
Dialysis, emergent outpatient visits for HF, hospitalizations and mortality will be recorded through Day 30 and Day 90. If an additional serum creatinine has been obtained as standard care near Day 30, it will also be recorded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693745
|United States, California|
|San Diego Veterans Affairs Hospital|
|San Diego, California, United States, 92161|
|United States, New York|
|New York Methodist Hospital|
|Brooklyn, New York, United States, 11215|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|UMC Groningen (UMCG)|
|Groningen, Netherlands, 9700 RB|
|University Hospital - Basel|
|Basel, Switzerland, 4031|
|Principal Investigator:||Alan Maisel, MD||UCSD, San Diego VA Hospital|