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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Abbott Diagnostics Division
Alere, Inc.
Information provided by (Responsible Party):
Alere San Diego
ClinicalTrials.gov Identifier:
NCT01291836
First received: February 7, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291836

Locations
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
Greece
Athens University Hospital Attikon
Athens, Greece, 12461
Ireland
University Hospital Dublin
Dublin, Ireland, 4
Italy
Clinica Mediterranea
Naples, Italy
Monasterio Foundation for Medical Research and Public Health
Pisa, Italy
Netherlands
University of Groningen Medical Center
Groningen, GZ Groningen, Netherlands, 9713
Spain
Hospital Clínico Universitario Valencia
Valencia, Spain
Switzerland
Universitätsspital Basel
Basel, Petersgraben, Switzerland, 4
Sponsors and Collaborators
Alere San Diego
Abbott Diagnostics Division
Alere, Inc.
Investigators
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

No publications provided

Responsible Party: Alere San Diego
ClinicalTrials.gov Identifier: NCT01291836     History of Changes
Other Study ID Numbers: DDDP-09EE-081
Study First Received: February 7, 2011
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 22, 2014