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

NCT05963126 | Recruiting

• 2 other identifiers: MHUFA-hypertension CKDRVO-FNOs/2023 17
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Hypertension

Keywords

Arterial Hypertension; Resistant Arterial Hypertension; Chronic Kidney Disease; Fetuin A; DNLite IVD103

Outcome Measures

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.

  1 year

Secondary Outcomes (3)

• Urine biomarker DNLite IVD103 - primary aim

  1 year

• Urine biomarker DNLite IVD103 - secondary aim

  1 year

• Urine biomarker DNLite IVD103 - correlation

  1 year

Study Arms (1)

Patients with hypertension, resistant hypertension, and secondary hypertension

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

Other: No intervention.

Interventions

No intervention. OTHER

No intervention.

Patients with hypertension, resistant hypertension, and secondary hypertension

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Arterial hypertension treated by at least one antihypertensive agent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava, - Department of Internal Medicine and Cardiology

Ostrava, Czech Republic, 70852, Czechia

RECRUITING

Related Links

• The DNlite Test - Products - BIOPREVENTIVE MEDICINE

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples of urine.

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zdeněk Ramík, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)