Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF

Completed

Conditions studied: Acute Decompensated Heart Failure

In brief

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.

Key facts

Study ID

NCT00693745

Run by

Abbott RDx Cardiometabolic

People needed

231

Starts

2008-09-01

Expected to finish

2010-07-01

Last updated by the study team

2010-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 .

Where it is running

• San Diego Veterans Affairs Hospital — San Diego, California, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• Ohio State University — Columbus, Ohio, United States
• UMC Groningen (UMCG) — Groningen, Netherlands
• University Hospital - Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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