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Fetuin A as a Predictor of Deterioration of Renal Function in Hypertonic Patients

ConditionArterial Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospital Ostrava

About this trial

Commonly used parameters (creatinine, estimated glomerular filtration rate, and urine albumin/creatinine ratio) for prediction of decline of renal function are sensitive for advanced kidney impairment. Modified human urine Fetuin A (urine Fetuin A) with specific modification in urine (Fetuin A) can earlier predict the progression of kidney disease in patients with diabetes. Studies evaluating urine Fetuin A in hypertonic patients are still lacking.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Arterial hypertension treated by at least one antihypertensive agent

Disqualifiers

Diabetes mellitus of any type, defined as fasting glucose >7,0 mmol/l or any glycemia >11,0 mmol/l, or HbA1c>48 mmol/mol

Decompensated arterial hypertension defined as office blood pressure >180/110 mmHg or on Ambulatory Blood Pressure Monitoring (ABPM)

Patient with renal replacement therapy

Present rheumatoid disease (rheumatoid arthritis, systemic lupus, sclerodermia, dermatomyositis, Inflammatory Bowel Disease, etc.), positivity of antinuclear antibody (ANA) / extractable nuclear antigen (ENA) screening

Trial population

Patients with hypertension and resistant hypertension followed-up in the Hypertension excellence centre and Lipid centre in University Hospital Ostrava.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention.

    Other intervention

    No intervention.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with hypertension, resistant hypertension, and secondary hypertension1 intervention

Trial outcomes

Primary outcomes

1

Glomerular filtration rate

Decline of glomerular filtration rate in 1-year follow-up of each patient in a total of 3 visits at times: 0 months, 6 months, and 12 months.

Time frame
1 year

Secondary outcomes

1

Urine biomarker DNLite IVD103 - primary aim

Evaluation of urine biomarker DNLite IVD103 and its ability to predict deterioration of renal function defined as a decline of glomerular filtration rate in patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension. Diabetic nephropathy in vitro diagnostics (DNLite IVD103) is a colorimetric immunoassay intended for quantitative measurement of unique Fetuin-A with specific post-translational modification in human urine.

Time frame
1 year
2

Urine biomarker DNLite IVD103 - secondary aim

Evaluation of urine biomarker DNLite IVD103 and its ability to predict deterioration of renal function defined in patients with manifested cardiovascular disease, dyslipidemia (yes/no).

Time frame
1 year
3

Urine biomarker DNLite IVD103 - correlation

Evaluation of the correlation of biomarker DNLite IVD103 in patients' plasma and in urine (yes/no).

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Ostrava

Lead sponsor

Source ClinicalTrials.gov
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