Acute Decompensated Heart FailureAKINESISNCT01291836
Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin Evaluation of Symptomatic Heart Failure Study
An observational study of Acute Decompensated Heart Failure and Acute Kidney Injury, run by Alere San Diego at 13 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure, Acute Kidney Injury
- How many people
- 930 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Dec 2010to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be enrolled primarily from hospital emergency rooms located at various academic centers located throughout the USA and Europe.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
United States6 sites
New York Methodist Hospital
Brooklyn, New York, 11215
Henry Ford Health System
Detroit, Michigan, 48208
Kansas University Medical Center
Kansas City, Kansas, 66160
Virginia Commonweath University Medical Center
Richmond, Virginia, 23298
University of California San Diego Medical Center
San Diego, California, 92103
San Diego Veterans Administration Hospital
San Diego, California, 92161
Italy2 sites
Clinica Mediterranea
Naples
Monasterio Foundation for Medical Research and Public Health
Pisa
Netherlands1 site
University of Groningen Medical Center
Groningen, GZ Groningen, 9713
About this study
Official title: 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.
- Keywords
- Acute Kidney Injury (AKI), Acute Decompensated Heart Failure (ADHF), Neutrophil Gelatinase Associated Lipocalin (NGAL), biomarker
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
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.
Measured: ~30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alere San Diego
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott Diagnostics Division, Alere, Inc.
- Responsible party
- Sponsor
- Investigators
- Alan Maisel, MD, Principal investigator, University of California, San Diego Medical Center/Veterans Affairs Medical Center, San DiegoPatrick Murray, MD, Principal investigator, University College of Dublin School of Medicine and Medical Science/Mater Misericordiae University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291836
- Sponsor's protocol ID
- DDDP-09EE-081
- Acronym
- AKINESIS
- Status last verified
- Dec 2023
- First submitted
- 7 Feb 2011
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Duff S, Wettersten N, Horiuchi Y, van Veldhuisen DJ, Raturi S, Irwin R, Cote JM, Maisel A, Ix JH, Murray PT. Absence of Kidney Tubular Injury in Patients With Acute Heart Failure With Acute Kidney Injury. Circ Heart Fail. 2024 Nov;17(11):e011751. doi: 10.1161/CIRCHEARTFAILURE.123.011751. Epub 2024 Oct 18.
PubMed 39421939Maisel 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.
PubMed 27659464
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin (N-GAL) Evaluation of Symptomatic Heart Failure Study (AKINESIS)
- ClinicalTrials.gov ID
- NCT01291836
- Acronym / sponsor ID
- AKINESIS / DDDP-09EE-081
- Keywords
- Acute Kidney Injury (AKI), Acute Decompensated Heart Failure (ADHF), Neutrophil Gelatinase Associated Lipocalin (NGAL), biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 930 participants (actual)
- Lead sponsor
- Alere San DiegoIndustry (pharma, biotech, devices)
- Collaborators
- Abbott Diagnostics Division, Alere, Inc.
- Study start
- Dec 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled primarily from hospital emergency rooms located at various academic centers located throughout the USA and Europe.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39421939Duff S, Wettersten N, Horiuchi Y, van Veldhuisen DJ, Raturi S, Irwin R, Cote JM, Maisel A, Ix JH, Murray PT. Absence of Kidney Tubular Injury in Patients With Acute Heart Failure With Acute Kidney Injury. Circ Heart Fail. 2024 Nov;17(11):e011751. doi: 10.1161/CIRCHEARTFAILURE.123.011751. Epub 2024 Oct 18.
- Derived from this study: PubMed 27659464Maisel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Maisel, MD principal investigator
University of California, San Diego Medical Center/Veterans Affairs Medical Center, San Diego
Patrick Murray, MD principal investigator
University College of Dublin School of Medicine and Medical Science/Mater Misericordiae University Hospital
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure and Acute Kidney Injury, run by Alere San Diego at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Italy, Greece, Ireland, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: First week of hospitalization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291836, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.