Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Cardiology, Hospital
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:2/21/2018
Start Date:December 2010
End Date:June 2015

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Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin (N-GAL) Evaluation of Symptomatic Heart Failure Study (AKINESIS)

AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in
predicting worsening kidney function in patients who present with acute heart failure (AHF)
and who are treated with diuretics. It is believed that rising NGAL levels in the blood
and/or urine can predict acute kidney injury. It is also believed that patients who are
admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.


Inclusion Criteria:

- Subjects must be at least 18 years of age.

- Subjects must present to the hospital with one or more signs or symptoms of acute
heart failure (AHF). Signs and symptoms include shortness of breath from walking,
rales or crackles, galloping heart rhythm, jugular venous distension, trouble
breathing at rest or when lying down, waking breathless at night, using more than 2
pillows to sleep, tiring easily, swelling of feet, ankles or legs, frequent coughing,
a cough that produces mucous or blood-tinged sputum, or a dry cough when lying flat.

- Subjects must receive IV diuretics, or there must be an intent to treat with IV
diuretics.

- Subjects must be willing and able to comply with all aspects of the protocol.

- Subjects must provide signed informed consent.

Exclusion Criteria:

- Subjects that present with symptoms consistent with acute coronary syndromes (AMI or
UA) as the chief cause of the current episode of AHF.

- Subjects already on dialysis prior to enrollment or if dialysis initiation is already
planned during the current hospital visit.

- Subjects that have had any major organ transplant (heart, lung, kidney, or liver).

- Subjects that have participated in a drug treatment study within the past 30 days or
if they have already been enrolled as a subject in this study.

- Women who verbally report being pregnant at the time of screening and anyone belonging
to a vulnerable population that is deemed inappropriate for inclusion into the study
by the IRB/EC.
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Detroit, Michigan 48202
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San Diego, California 92161
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