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

Sponsor

University Hospital Ostrava (Other)

Overall Status

Recruiting

CT.gov ID

NCT05963126

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypertension	Other: No intervention.

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Modified Urine Fetuin A as a Predictor of Deterioration of Renal Function in Patients With Resistant and Non-resistant Hypertension

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Patients with hypertension, resistant hypertension, and secondary hypertension Patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension.	Other: No intervention. No intervention.

Arm

Intervention/Treatment

Patients with hypertension, resistant hypertension, and secondary hypertension

Patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension.

Other: No intervention.

No intervention.

Outcome Measures

Primary Outcome Measures

Glomerular filtration rate [1 year]
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.

Secondary Outcome Measures

Urine biomarker DNLite IVD103 - primary aim [1 year]
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.
Urine biomarker DNLite IVD103 - secondary aim [1 year]
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).
Urine biomarker DNLite IVD103 - correlation [1 year]
Evaluation of the correlation of biomarker DNLite IVD103 in patients' plasma and in urine (yes/no).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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