Status:
COMPLETED
Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF
Lead Sponsor:
Abbott RDx Cardiometabolic
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 h...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Males and females 18 years of age or older;
- Patients presenting to the emergency department / hospital with symptoms of new or decompensated heart failure and who will be treated with at least one dose of IV diuretic;
- Ability to draw blood samples for baseline NGAL, BNP and creatinine levels either prior to the administration of the first dose of IV diuretic or within 1 hour after the first dose of an IV diuretic
- Ability to provide written informed consent from subject or their authorized representative.
Exclusion
- Acute myocardial infarction or active ischemia;
- Patients who are intubated or otherwise not able to communicate or comply with study assessments;
- Cardiogenic shock or any other clinical condition that would contraindicate the administration of an IV agent with potent vasodilating properties;
- Known history of marked renal insufficiency (e.g., usual serum creatinine ≥ 3.0 mg/dL), on dialysis (either acute of chronic) or in imminent need of dialysis at enrollment;
- Prisoners or other institutionalized or vulnerable individuals;
- Participation in an interventional clinical study within the previous 30 days;
- Unlikely to be willing or able to comply with study procedures, including the follow-up at 30 and 90 days .
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00693745
Start Date
September 1 2008
End Date
July 1 2010
Last Update
October 22 2010
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
San Diego Veterans Affairs Hospital
San Diego, California, United States, 92161
2
New York Methodist Hospital
Brooklyn, New York, United States, 11215
3
Ohio State University
Columbus, Ohio, United States, 43210
4
UMC Groningen (UMCG)
Groningen, Netherlands, 9700 RB