Acute Decompensated Heart Failure, Acute Kidney Injury
Conditions
Keywords
Acute Kidney Injury (AKI), Acute Decompensated Heart Failure (ADHF), Neutrophil Gelatinase Associated Lipocalin (NGAL), biomarker
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.
Interventions
None listed
Sponsors
Abbott Diagnostics Division
Alere, Inc.
Alere San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | ~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. |
Countries
Greece, Ireland, Italy, Netherlands, Spain, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrollment Group-No Treatment Arms. All subjects underwent the same protocol procedures no stratification. | 930 |
| Total | 930 |
Baseline characteristics
| Characteristic | Enrollment Group-No Treatment Arms. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 586 Participants |
| Age, Categorical Between 18 and 65 years | 344 Participants |
| Region of Enrollment Germany | 1 participants |
| Region of Enrollment Greece | 27 participants |
| Region of Enrollment Ireland | 41 participants |
| Region of Enrollment Italy | 110 participants |
| Region of Enrollment Netherlands | 97 participants |
| Region of Enrollment Spain | 15 participants |
| Region of Enrollment Switzerland | 52 participants |
| Region of Enrollment United States | 587 participants |
| Sex: Female, Male Female | 354 Participants |
| Sex: Female, Male Male | 576 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 930 | 0 / 71 |
| serious Total, serious adverse events | 0 / 930 | 0 / 71 |
Outcome results
Primary
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.
Time frame: ~30 days
Population: Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrollment Group | 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. | 0.650 Probability classifying AKI from non-AKI |
Comparison: Null Hypothesis: AUC ≤0.55, using a one-sided z-test at a significance level of 0.025. 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 1.95% CI: [0.598, 0.702]
Primary
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.
Time frame: First week of hospitalization.
Population: Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enrollment Group | 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. | 0.658 Probability classifying AKI from non-AKI |
Comparison: Null Hypothesis: ROC AUC of 0.58; using a one-sided z-test at a significance level of 0.025. 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 1.95% CI: [0.586, 0.73]