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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Alere San Diego.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: February 9, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Abbott Diagnostics Division
Alere, Inc.
Information provided by (Responsible Party):
Alere San Diego
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.

Acute Decompensated Heart Failure Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin (N-GAL) Evaluation of Symptomatic Heart Failure Study (AKINESIS)

Resource links provided by NLM:

Further study details as provided by Alere San Diego:

Biospecimen Retention:   Samples Without DNA
Urine Samples, Plasma Samples

Estimated Enrollment: 800
Study Start Date: December 2010
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291836

United States, California
University of California San Diego Medical Center
San Diego, California, United States, 92103
San Diego Veterans Administration Hospital
San Diego, California, United States, 92161
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48208
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, Virginia
Virginia Commonweath University Medical Center
Richmond, Virginia, United States, 23298
Athens University Hospital Attikon
Athens, Greece, 12461
University Hospital Dublin
Dublin, Ireland, 4
Clinica Mediterranea
Naples, Italy
Monasterio Foundation for Medical Research and Public Health
Pisa, Italy
University of Groningen Medical Center
Groningen, GZ Groningen, Netherlands, 9713
Hospital Clínico Universitario Valencia
Valencia, Spain
Universitätsspital Basel
Basel, Petersgraben, Switzerland, 4
Sponsors and Collaborators
Alere San Diego
Abbott Diagnostics Division
Alere, Inc.
Principal Investigator: Alan Maisel, MD University of California, San Diego Medical Center/Veterans Affairs Medical Center, San Diego
Principal Investigator: Patrick Murray, MD University College of Dublin School of Medicine and Medical Science/Mater Misericordiae University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alere San Diego
ClinicalTrials.gov Identifier: NCT01291836     History of Changes
Other Study ID Numbers: DDDP-09EE-081
First Submitted: February 7, 2011
First Posted: February 9, 2011
Last Update Posted: October 12, 2017
Last Verified: June 2014

Keywords provided by Alere San Diego:
Acute Kidney Injury (AKI)
Acute Decompensated Heart Failure (ADHF)
Neutrophil Gelatinase Associated Lipocalin (NGAL)

Additional relevant MeSH terms:
Wounds and Injuries
Heart Failure
Acute Kidney Injury
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases