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

NCT ID: NCT05963126

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with hypertension, resistant hypertension, and secondary hypertension

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

No intervention.

Intervention Type OTHER

No intervention.

Interventions

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No intervention.

No intervention.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zdeněk Ramík, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

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University Hospital Ostrava, - Department of Internal Medicine and Cardiology

Ostrava, Czech Republic, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jiří Hynčica

Role: CONTACT

0042059737 ext. 2587

Facility Contacts

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Jiří Hynčica

Role: primary

0042059737 ext. 2587

Related Links

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https://bpmbiotech.com

The DNlite Test - Products - BIOPREVENTIVE MEDICINE

Other Identifiers

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MHUFA-hypertension CKD

Identifier Type: -

Identifier Source: org_study_id

RVO-FNOs/2023 17

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

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