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

July 18, 2023 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Czech Republic
      • Ostrava, Czech Republic, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava, - Department of Internal Medicine and Cardiology
        • Contact:
        • Principal Investigator:
          • Zdeněk Ramík, MD
        • Sub-Investigator:
          • Iveta Bystroňová, MSc
        • Sub-Investigator:
          • Janula Stromská, MD
        • Sub-Investigator:
          • Pavla Jadrníčková, MD
        • Sub-Investigator:
          • Lukáš Štos, MD
        • Sub-Investigator:
          • Eva Široká

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine biomarker DNLite IVD103 - primary aim
Time Frame: 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.
1 year
Urine biomarker DNLite IVD103 - secondary aim
Time Frame: 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).
1 year
Urine biomarker DNLite IVD103 - correlation
Time Frame: 1 year
Evaluation of the correlation of biomarker DNLite IVD103 in patients' plasma and in urine (yes/no).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Zdeněk Ramík, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHUFA-hypertension CKD
  • RVO-FNOs/2023 17 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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