Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000955516
Ethics application status
Approved
Date submitted
31/07/2015
Date registered
11/09/2015
Date last updated
15/06/2021
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The IDENTAKIT-HF trial: Identification of optimal markers of Acute Kidney Injury (AKI) in patients with Acute Decompensated Heart Failure (ADHF)
Scientific title
Identification of optimal urine and blood biomarkers of acute kidney injury (AKI) in patients with Acute Decompensated Heart Failure (ADHF)
Secondary ID [1] 287178 0
none
Universal Trial Number (UTN)
Trial acronym
The IDENTAKIT-HF trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute decompensated heart failure 295748 0
acute kidney injury 295749 0
Condition category
Condition code
Cardiovascular 296025 296025 0 0
Other cardiovascular diseases
Renal and Urogenital 296026 296026 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The IDENTAKIT-HF study is a multicentre longitudinal prospective cohort study of a panel of promising candidate urine and blood biomarkers of evolving Acute Kidney Injury (AKI) to establish the temporal profiles of selected renal injury biomarkers in Acute Decompensated Heart Failure (ADHF) and identify a candidate optimal panel of selected renal injury biomarkers for detection of AKI and to test miRNAs in plasma and urine as early markers of AKI
400 eligible patients admitted to Christchurch or Auckland hospital with ADHF will be enrolled on hospital admission and serial urine and blood samples will be taken during seven days Patients will receive usual care for ADHF. Samples of both urine and blood for AKI biomarkers and creatinine will be collected on admission (0 hours), at 6, 12, 24, 48 hours and days 5, 6 and 7. Plasma creatinine and eGFR will be reviewed at 30, 90, 180 days and 1 year after entry. There is no randomisation to treatment, however for the purposes of producing a development and validation cohort there is randomisation of samples. A computer generated randomisation sequence arranged in permuted blocks will be generated prior to any recruitment. In 200 patient samples, randomly selected from the total of 400 patient samples, the temporal profiles of renal injury biomarkers will be used to identify a candidate optimal panel of biomarkers for detection of AKI. This panel will be validated in the other 200 patients by an assessment of biomarker performance to detect AKI.
Intervention code [1] 292452 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295695 0
The Incidence of AKI in ADHF.
Timepoint [1] 295695 0
Assessed by an increase in Serum Creatinine (SCr) by greater than or equal to 26.4 l micromol/l within any 48 hour period from admission till discharge; or an increase in SCr to greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days at any point from admission to discharge.
Secondary outcome [1] 316555 0
The association with hospital length of stay for each novel candidate biomarkers will be compared with serum creatinine and with serum cystatin C
Timepoint [1] 316555 0
Timing for secondary outcomes 3,4,5 30 days, 90 days, 180 days and 365 days after enrolment.
Secondary outcome [2] 316556 0
The ability to predict in-hospital dialysis for each novel candidate biomarkers will be compared with serum creatinine and with serum cystatin C.
Timepoint [2] 316556 0
Timing for secondary outcomes 3,4,5 30 days, 90 days, 180 days and 365 days after enrolment.
Secondary outcome [3] 316557 0
The ability to predict dialysis dependence for each novel candidate biomarkers will be compared with serum creatinine and with serum cystatin C.
Timepoint [3] 316557 0
Timing for secondary outcomes 3,4,5 30 days, 90 days, 180 days and 365 days after enrolment.
Secondary outcome [4] 316558 0
The ability to predict mortality for each novel candidate biomarkers will be compared with serum creatinine and with serum cystatin C.
Timepoint [4] 316558 0
Timing for secondary outcomes 3,4,5 30 days, 90 days, 180 days and 365 days after enrolment.
Secondary outcome [5] 316559 0
The ability to predict the establishment of chronic kidney disease (GFR <60 ml/min/1.73m2 ) for each novel candidate biomarkers will be compared with serum creatinine and with serum cystatin C.
Timepoint [5] 316559 0
Timing for secondary outcomes 3,4,5 30 days, 90 days, 180 days and 365 days after enrolment.
Secondary outcome [6] 316560 0
The ability to predict major adverse cardiac events for each novel candidate biomarkers will be compared with serum creatinine and with serum cystatin C.
Timepoint [6] 316560 0
Timing for secondary outcomes 3,4,5 30 days, 90 days, 180 days and 365 days after enrolment.

Eligibility
Key inclusion criteria
Provide signed and dated informed consent form
Willing to comply with all study procedures and be available for the duration of the study
Living independently (ie, not hospital care dependent)
Admitted with ADHF as evidenced by typical clinical features plus either radiological evidence of HF or an NTproBNP level >1000pg/ml.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A primary diagnosis of acute coronary syndrome (ACS), myocarditis/pericarditis, pericardial constriction,
A life expectancy due to non-cardiac disease of <6 months,
A concurrent severe hepatic or pulmonary disease A concurrent severe hepatic disease
Severe renal impairment (plasma creatinine >250 micromol/L),
Severe valvular disease requiring surgery,
Severe aortic stenosis (valve area <1 cm^2), or HF due to mitral stenosis
A patient under consideration for cardiac transplantation
Without a urine sample within 4 hours of admission
With a prior eGFR <15 ml/min/1.73m2
On dialysis
Unable to comply with study protocol requirements
Unwilling or unable to consent
Already actively enrolled in this study

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
23/09/2015
Date of last participant enrolment
Anticipated
31/07/2020
Actual
26/10/2019
Date of last data collection
Anticipated
Actual
26/03/2021
Sample size
Target
400
Accrual to date
Final
86
Recruitment outside Australia
Country [1] 7058 0
New Zealand
State/province [1] 7058 0
Christchurch and Auckland

Funding & Sponsors
Funding source category [1] 291744 0
Government body
Name [1] 291744 0
Health Research Council of New Zealand
Country [1] 291744 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Christchurch Heart Institute Trust
Address
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 290478 0
None
Name [1] 290478 0
Address [1] 290478 0
Country [1] 290478 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293263 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 293263 0
C/- MEDSAFE, Level 6, Deloitte House.
10 Brandon Street,
PO Box 5013.
Wellington.6011
Ethics committee country [1] 293263 0
New Zealand
Date submitted for ethics approval [1] 293263 0
Approval date [1] 293263 0
03/03/2015
Ethics approval number [1] 293263 0
15/CEN/15

Summary
Brief summary
IDENTAKIT-HF is a multicentre longitudinal prospective cohort study of a panel of promising candidate urine and blood biomarkers of evolving AKI in ADHF patients. 400 patients will be recruited and blood and urine collected at multiple time points over seven days . There is no randomisation to treatment, however for the purposes of producing a development and validation cohort there is randomisation of samples. A computer generated randomisation sequence arranged in permuted blocks will be generated prior to any recruitment.In 200 patient samples, randomly selected from the total of 400 patient samples, the temporal profiles of renal injury biomarkers will be used to identify a candidate optimal panel of biomarkers for detection of AKI. This panel will be validated in the other 200 patients by an assessment of biomarker performance to detect AKI. Ancillary investigations, abdominal ultrasound and trans-thoracic echocardiography, will be performed during admission to establish relevant cardiac and kidney parameters. Also assessed will be the ability of candidate biomarkers to predict major adverse cardiac and kidney outcomes from patients with both HF and AKI, to predict recovery of renal function after intensified managed of AHF, and to distinguish between predominantly right or left HF.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59162 0
Prof Zoltan Endre
Address 59162 0
Department Nephrology
Prince of Wales Hospital
Barker Street
Randwick
New South Wales 2031
Country 59162 0
Australia
Phone 59162 0
+61 2 9382 4419
Fax 59162 0
+61 2 9382 4409
Email 59162 0
[email protected]
Contact person for public queries
Name 59163 0
Lorraine Skelton
Address 59163 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 59163 0
New Zealand
Phone 59163 0
+6433641063
Fax 59163 0
+6433641115
Email 59163 0
[email protected]
Contact person for scientific queries
Name 59164 0
John Pickering
Address 59164 0
Department of Medicine
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 59164 0
New Zealand
Phone 59164 0
+64212537877
Fax 59164 0
Email 59164 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.