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

NCT00693745 | Completed

• 1 other identifier: BSTE-0405
• Study Type: observational
• Target: 231
• Locations: 3 countries
• Sites: 5

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 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.

Conditions

Acute Decompensated Heart Failure

Keywords

Acutely

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 diuretic.

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 .

Sponsors & Collaborators

• Abbott RDx Cardiometabolic: lead

Study Sites (5)

San Diego Veterans Affairs Hospital

San Diego, California, 92161, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

UMC Groningen (UMCG)

Groningen, 9700 RB, Netherlands

Location

University Hospital - Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Maisel AS, Mueller C, Fitzgerald R, Brikhan R, Hiestand BC, Iqbal N, Clopton P, van Veldhuisen DJ. Prognostic utility of plasma neutrophil gelatinase-associated lipocalin in patients with acute heart failure: the NGAL EvaLuation Along with B-type NaTriuretic Peptide in acutely decompensated heart failure (GALLANT) trial. Eur J Heart Fail. 2011 Aug;13(8):846-51. doi: 10.1093/eurjhf/hfr087.

  PMID: 21791540 DERIVED

Study Officials

• Alan Maisel, MD

  UCSD, San Diego VA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 9, 2008
• Study Start: September 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 22, 2010

Record last verified: 2010-10

Locations

CH (1); NL (1); US (3)