Clinical trial NCT05963126: Fetuin A as a Predictor of Deterioration of Renal Function in Hypertonic Patients
Official title: Modified Urine Fetuin A as a Predictor of Deterioration of Renal Function in Patients With Resistant and Non-resistant Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arterial Hypertension
Keywords: Arterial Hypertension
Resistant Arterial Hypertension
Chronic Kidney Disease
Fetuin A
DNLite IVD103
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypertension and resistant hypertension followed-up in the Hypertension excellence centre and Lipid centre in University Hospital Ostrava.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: 1 year
Secondary outcomes:
measure: Urine biomarker DNLite IVD103 - primary aim
timeFrame: 1 year
measure: Urine biomarker DNLite IVD103 - secondary aim
timeFrame: 1 year
measure: Urine biomarker DNLite IVD103 - correlation
timeFrame: 1 year
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava, - Department of Internal Medicine and Cardiology
state: Czech Republic
Study officials:
affiliation: University Hospital Ostrava
name: Zdeněk Ramík, MD
role: PRINCIPAL_INVESTIGATOR
References: