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

University Hospital Ostrava200 enrolled

Overview

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.

Arterial hypertension and diabetes are the most common cause of chronic kidney disease. Commonly used parameters for the evaluation of renal function (plasma creatinine, estimated glomerular filtration rate, and urine albumin/creatinine ratio) are sensitive to advanced kidney disease. Parameters predicting early kidney impairment are still lacking. Modified human urine Fetuin A with specific modification in urine (urine Fetuin A) presents a new biomarker that seems to be promising in the early prediction of kidney disease in patients with diabetes without microalbuminuria. Studies evaluating urine Fetuin A in hypertonic patients are still lacking.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Arterial Hypertension

Interventions

No intervention.OTHER

No intervention.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Arterial hypertension treated by at least one antihypertensive agent Exclusion Criteria: * 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 * Acute infection defined as C-Reactive Protein (CRP) \>50 mg/l * Severe impairment of liver function defined as cirrhosis, Alanine Transaminase or ASpartate Transferase (ALT or AST) \>10 µkat/l * Terminal incurable illness

Locations (1)

University Hospital Ostrava, - Department of Internal Medicine and Cardiology

Ostrava, Czech Republic, Czechia

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

Central Contacts

Jiří Hynčica

CONTACT

0042059737 jiri.hyncica@fno.cz

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.