Clinical trial NCT01291836: Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study
Official title: Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin (N-GAL) Evaluation of Symptomatic Heart Failure Study (AKINESIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Decompensated Heart Failure
Acute Kidney Injury
Keywords: Acute Kidney Injury (AKI)
Acute Decompensated Heart Failure (ADHF)
Neutrophil Gelatinase Associated Lipocalin (NGAL)
biomarker
Lead sponsor: Abbott RDx Cardiometabolic
Sponsor class: OTHER
Collaborators: name: Abbott Diagnostics Division
name: Alere, Inc.
First posted: 2011-02-09
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be enrolled primarily from hospital emergency rooms located at various academic centers located throughout the USA and Europe.

Brief 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.


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.

Primary outcomes:
measure: 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.
timeFrame: First week of hospitalization.
measure: 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.
timeFrame: ~30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: San Diego
country: United States
facility: San Diego Veterans Administration Hospital
state: California
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Richmond
country: United States
facility: Virginia Commonweath University Medical Center
state: Virginia
city: Athens
country: Greece
facility: Athens University Hospital Attikon
city: Dublin
country: Ireland
facility: University Hospital Dublin
city: Naples
country: Italy
facility: Clinica Mediterranea
city: Pisa
country: Italy
facility: Monasterio Foundation for Medical Research and Public Health
city: Groningen
country: Netherlands
facility: University of Groningen Medical Center
state: GZ Groningen
city: Valencia
country: Spain
facility: Hospital Clínico Universitario Valencia
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Petersgraben
Study officials:
affiliation: University of California, San Diego Medical Center/Veterans Affairs Medical Center, San Diego
name: Alan Maisel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College of Dublin School of Medicine and Medical Science/Mater Misericordiae University Hospital
name: Patrick Murray, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.