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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00693745 |
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Date of registration:
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05/06/2008 |
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Primary sponsor: |
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Public title:
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Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF
GALLANT |
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Scientific title:
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NGAL Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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231 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00693745 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Netherlands
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Switzerland
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United States
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Contacts
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Name:
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Alan Maisel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UCSD, San Diego VA Hospital |
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Key inclusion & exclusion criteria
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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 .
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Decompensated Heart Failure
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Secondary ID(s)
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BSTE-0405
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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