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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Decompensated Heart Failure, Acute Kidney Injury

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the Efficacy of the Triage NGAL Test as an Aid to Diagnosis of Acute Kidney Injury (AKI) in Patients Admitted to the Hospital With Symptoms of Acute Heart Failure. | Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1. | First week of hospitalization. | 
| Evaluating the Efficacy of the Triage NGAL Test as an Aid in Predicting Poorer Outcomes in Patients Admitted to the Hospital With Admitted With Symptoms of Acute Heart Failure. | Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1. |  30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarker, Acute Kidney Injury (AKI), Acute Decompensated Heart Failure (ADHF), Neutrophil Gelatinase Associated Lipocalin (NGAL)