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Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF (GALLANT)
This study is currently recruiting participants.
Verified by Biosite, November 2008
Sponsored by: Biosite
Information provided by: Biosite
ClinicalTrials.gov Identifier: NCT00693745
  Purpose

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.


Condition
Acute Decompensated Heart Failure

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: NGAL Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF

Further study details as provided by Biosite:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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 .
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693745

Contacts
Contact: Suzanne Williamson 858-805-2733 swilliamson@biosite.com
Contact: Kyle Fortner 858-805-3032 kfortner@biosite.com

Locations
United States, California
San Diego Veterans Affairs Hospital Not yet recruiting
San Diego, California, United States, 92161
Contact: Robert Fitzgerald, Ph.D.     858-552-8585 ext 1137     rlfitzgerald@vapop.ucsd.edu    
Principal Investigator: Robert Fitzgerald, Ph.D.            
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Paris Datillo, RN     718-780-5040     oswanawake@hotmail.com    
Principal Investigator: Robert H Birkhahn, MD            
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Lynn White, RN     614-293-5102     Lynn.White@osumc.edu    
Principal Investigator: Brian Heistand, MD            
Sponsors and Collaborators
Biosite
Investigators
Principal Investigator: Alan Maisel, MD UCSD, San Diego VA Hospital
  More Information

Responsible Party: Biosite, Inc. ( Suzanne Williamson )
Study ID Numbers: BSTE-0405
Study First Received: June 5, 2008
Last Updated: November 14, 2008
ClinicalTrials.gov Identifier: NCT00693745  
Health Authority: United States: Institutional Review Board

Keywords provided by Biosite:
Acutely

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009