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

This study has been completed.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00693745
First received: June 5, 2008
Last updated: October 21, 2010
Last verified: October 2010
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NGAL Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF

Resource links provided by NLM:


Further study details as provided by Biosite:

Enrollment: 231
Study Start Date: September 2008
Study Completion Date: July 2010
Primary Completion Date: April 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
San Diego Veterans Affairs Hospital
San Diego, California, United States, 92161
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Netherlands
UMC Groningen (UMCG)
Groningen, Netherlands, 9700 RB
Switzerland
University Hospital - Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Biosite
Investigators
Principal Investigator: Alan Maisel, MD UCSD, San Diego VA Hospital
  More Information

No publications provided by Biosite

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyle Fortner, CRA, Biosite, Inc.
ClinicalTrials.gov Identifier: NCT00693745     History of Changes
Other Study ID Numbers: BSTE-0405
Study First Received: June 5, 2008
Last Updated: October 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Biosite:
Acutely

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014