CClinicalTrials.gg
CompletedNCT00693745GALLANTUpdated Oct 22, 2010

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

An observational study in Acute Decompensated Heart Failure, sponsored by Abbott RDx Cardiometabolic. Completed at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-22.

Sponsored by Abbott RDx Cardiometabolic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
231
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Acute Decompensated Heart Failure

Browse trials for

Keywords

  • Acutely
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 231 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Abbott RDx Cardiometabolic is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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 .
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
231 participants (actual)
06

Study locations

5 sites
  • San Diego Veterans Affairs Hospital
    San Diego, California 92161, United States
  • New York Methodist Hospital
    Brooklyn, New York 11215, United States
  • Ohio State University
    Columbus, Ohio 43210, United States
  • UMC Groningen (UMCG)
    Groningen, 9700 RB, Netherlands
  • University Hospital - Basel
    Basel, 4031, Switzerland
07

References and documents

Publications

  • 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. PubMed 21791540 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00693745
Lead sponsor
Abbott RDx Cardiometabolic
First posted
Jun 9, 2008
Start date
Sep 2008
Primary completion
Apr 2010
Completion
Jul 2010
Last update
Oct 22, 2010

Study contacts

Alan Maisel, MD
principal investigator · UCSD, San Diego VA Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion