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

October 21, 2010 updated by: Biosite

NGAL Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • 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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosite

Investigators

  • Principal Investigator: Alan Maisel, MD, UCSD, San Diego VA Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (Estimate)

June 9, 2008

Study Record Updates

Last Update Posted (Estimate)

October 22, 2010

Last Update Submitted That Met QC Criteria

October 21, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSTE-0405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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