None listed
Conditions
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.
Interventions
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
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.
Sponsors
Christchurch Heart Institute Trust
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed