Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study
NCT ID: NCT01291836
Last Updated: 2024-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
930 participants
OBSERVATIONAL
2010-12-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Abbott Diagnostics Division
INDUSTRY
Alere, Inc.
INDUSTRY
Alere San Diego
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Maisel, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego Medical Center/Veterans Affairs Medical Center, San Diego
Patrick Murray, MD
Role: PRINCIPAL_INVESTIGATOR
University College of Dublin School of Medicine and Medical Science/Mater Misericordiae University Hospital
Locations
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University of California San Diego Medical Center
San Diego, California, United States
San Diego Veterans Administration Hospital
San Diego, California, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Henry Ford Health System
Detroit, Michigan, United States
New York Methodist Hospital
Brooklyn, New York, United States
Virginia Commonweath University Medical Center
Richmond, Virginia, United States
Athens University Hospital Attikon
Athens, , Greece
University Hospital Dublin
Dublin, , Ireland
Clinica Mediterranea
Naples, , Italy
Monasterio Foundation for Medical Research and Public Health
Pisa, , Italy
University of Groningen Medical Center
Groningen, GZ Groningen, Netherlands
Hospital Clínico Universitario Valencia
Valencia, , Spain
Universitätsspital Basel
Basel, Petersgraben, Switzerland
Countries
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References
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Duff S, Wettersten N, Horiuchi Y, van Veldhuisen DJ, Raturi S, Irwin R, Cote JM, Maisel A, Ix JH, Murray PT. Absence of Kidney Tubular Injury in Patients With Acute Heart Failure With Acute Kidney Injury. Circ Heart Fail. 2024 Nov;17(11):e011751. doi: 10.1161/CIRCHEARTFAILURE.123.011751. Epub 2024 Oct 18.
Maisel AS, Wettersten N, van Veldhuisen DJ, Mueller C, Filippatos G, Nowak R, Hogan C, Kontos MC, Cannon CM, Muller GA, Birkhahn R, Clopton P, Taub P, Vilke GM, McDonald K, Mahon N, Nunez J, Briguori C, Passino C, Murray PT. Neutrophil Gelatinase-Associated Lipocalin for Acute Kidney Injury During Acute Heart Failure Hospitalizations: The AKINESIS Study. J Am Coll Cardiol. 2016 Sep 27;68(13):1420-1431. doi: 10.1016/j.jacc.2016.06.055.
Other Identifiers
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DDDP-09EE-081
Identifier Type: -
Identifier Source: org_study_id
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