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

December 29, 2023 updated by: Alere San Diego

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

930

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12461
        • Athens University Hospital Attikon
  • Ireland
      • Dublin, Ireland, 4
        • University Hospital Dublin
  • Italy
      • Naples, Italy
        • Clinica Mediterranea
      • Pisa, Italy
        • Monasterio Foundation for Medical Research and Public Health
  • Netherlands
    • GZ Groningen
      • Groningen, GZ Groningen, Netherlands, 9713
        • University of Groningen Medical Center
  • Spain
      • Valencia, Spain
        • Hospital Clinico Universitario Valencia
  • Switzerland
    • Petersgraben
      • Basel, Petersgraben, Switzerland, 4
        • Universitätsspital Basel
  • United States
    • California
      • San Diego, California, United States, 92103
        • University of California San Diego Medical Center
      • San Diego, California, United States, 92161
        • San Diego Veterans Administration Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48208
        • Henry Ford Health System
    • New York
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonweath University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: First week of hospitalization.
Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.
First week of hospitalization.
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.
Time Frame: ~30 days
Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.
~30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alere San Diego

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimated)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDDP-09EE-081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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