Heart Failure Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

930

Study ID:

NCT01291836

Recruitment Status:

Completed

Sponsor:

Alere San Diego

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There are 9 Locations for this study

See Locations Near You

University of California San Diego Medical Center
San Diego California, 92103, United States
San Diego Veterans Administration Hospital
San Diego California, 92161, United States
Kansas University Medical Center
Kansas City Kansas, 66160, United States
Henry Ford Health System
Detroit Michigan, 48208, United States
New York Methodist Hospital
Brooklyn New York, 11215, United States
Virginia Commonweath University Medical Center
Richmond Virginia, 23298, United States
Athens University Hospital Attikon
Athens , 12461, Greece
University Hospital Dublin
Dublin , 4, Ireland
Clinica Mediterranea
Naples , , Italy
Monasterio Foundation for Medical Research and Public Health
Pisa , , Italy
University of Groningen Medical Center
Groningen GZ Groningen, 9713, Netherlands
Hospital Clínico Universitario Valencia
Valencia , , Spain
Universitätsspital Basel
Basel Petersgraben, 4, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

930

Study ID:

NCT01291836

Recruitment Status:

Completed

Sponsor:


Alere San Diego

How clear is this clinincal trial information?

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