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

NCT01291836 | Completed Results DMC

• 1 other identifier: DDDP-09EE-081
• Study Type: observational
• Target: 930
• Locations: 7 countries
• Sites: 13

Brief 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. It is also believed that patients who are admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.

Conditions

Acute Decompensated Heart Failure; Acute Kidney Injury

Keywords

Acute Kidney Injury (AKI); Acute Decompensated Heart Failure (ADHF); Neutrophil Gelatinase Associated Lipocalin (NGAL); biomarker

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  ~30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alere San Diego: lead
• Abbott Diagnostics Division: collaborator
• Alere, Inc.: collaborator

Study Sites (13)

University of California San Diego Medical Center

San Diego, California, 92103, United States

Location

San Diego Veterans Administration Hospital

San Diego, California, 92161, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Henry Ford Health System

Detroit, Michigan, 48208, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Virginia Commonweath University Medical Center

Richmond, Virginia, 23298, United States

Location

Athens University Hospital Attikon

Athens, 12461, Greece

Location

University Hospital Dublin

Dublin, 4, Ireland

Location

Clinica Mediterranea

Naples, Italy

Location

Monasterio Foundation for Medical Research and Public Health

Pisa, Italy

Location

University of Groningen Medical Center

Groningen, GZ Groningen, 9713, Netherlands

Location

Hospital Clínico Universitario Valencia

Valencia, Spain

Location

Universitätsspital Basel

Basel, Petersgraben, 4, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 39421939 DERIVED

• Maisel 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.

  PMID: 27659464 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Samples, Plasma Samples

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: William Arnold
• Organization: Alere San Diego

william.arnold@alere.com

858-505-2000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 9, 2011
• Study Start: December 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2015
• Last Updated: January 3, 2024
• Results First Posted: February 19, 2018

Record last verified: 2023-12

Locations

NL (1); ES (1); CH (1); GR (1); IT (2); US (6); IE (1)