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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alere San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott Diagnostics Division
Alere, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings