![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Biosite |
---|---|
Information provided by: | Biosite |
ClinicalTrials.gov Identifier: | NCT00693745 |
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: | Case-Only, Prospective |
Official Title: | NGAL Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
Exclusion Criteria:
Contact: Suzanne Williamson | 858-805-2733 | swilliamson@biosite.com |
Contact: Kyle Fortner | 858-805-3032 | kfortner@biosite.com |
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 |
Principal Investigator: | Alan Maisel, MD | UCSD, San Diego VA Hospital |
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 |
Acutely |
Natriuretic Peptide, Brain Heart Failure Heart Diseases |
Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |