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

NCT ID: NCT01291836

Last Updated: 2024-01-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

930 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-06-30

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.

Detailed Description

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Conditions

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Acute Decompensated Heart Failure Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Diagnostics Division

INDUSTRY

Sponsor Role collaborator

Alere, Inc.

INDUSTRY

Sponsor Role collaborator

Alere San Diego

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

San Diego Veterans Administration Hospital

San Diego, California, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

New York Methodist Hospital

Brooklyn, New York, United States

Site Status

Virginia Commonweath University Medical Center

Richmond, Virginia, United States

Site Status

Athens University Hospital Attikon

Athens, , Greece

Site Status

University Hospital Dublin

Dublin, , Ireland

Site Status

Clinica Mediterranea

Naples, , Italy

Site Status

Monasterio Foundation for Medical Research and Public Health

Pisa, , Italy

Site Status

University of Groningen Medical Center

Groningen, GZ Groningen, Netherlands

Site Status

Hospital Clínico Universitario Valencia

Valencia, , Spain

Site Status

Universitätsspital Basel

Basel, Petersgraben, Switzerland

Site Status

Countries

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United States Greece Ireland Italy Netherlands Spain Switzerland

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.

Reference Type DERIVED
PMID: 39421939 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27659464 (View on PubMed)

Other Identifiers

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DDDP-09EE-081

Identifier Type: -

Identifier Source: org_study_id

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