Arterial HypertensionNCT05963126
Fetuin A as a Predictor of Deterioration of Renal Function in Hypertonic Patients
An observational study of Arterial Hypertension, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arterial Hypertension
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypertension and resistant hypertension followed-up in the Hypertension excellence centre and Lipid centre in University Hospital Ostrava.
Who may be able to join
- Arterial hypertension treated by at least one antihypertensive agent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava, - Department of Internal Medicine and Cardiology
Ostrava, Czech Republic, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Zdeněk Ramík, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Arterial Hypertension
- Being tested
- No intervention.
- Keywords
- Arterial Hypertension, Resistant Arterial Hypertension, Chronic Kidney Disease, Fetuin A, DNLite IVD103
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hypertension, resistant hypertension, and secondary hypertension | Patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Urine biomarker DNLite IVD103 - primary aim
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.
Measured: 1 year
Urine biomarker DNLite IVD103 - secondary aim
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).
Measured: 1 year
Urine biomarker DNLite IVD103 - correlation
Evaluation of the correlation of biomarker DNLite IVD103 in patients' plasma and in urine (yes/no).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zdeněk Ramík, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963126
- Sponsor's protocol ID
- MHUFA-hypertension CKD
- Other IDs
- RVO-FNOs/2023 17
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Urine Fetuin A as a Predictor of Deterioration of Renal Function in Patients With Resistant and Non-resistant Hypertension
- ClinicalTrials.gov ID
- NCT05963126
- Acronym / sponsor ID
- MHUFA-hypertension CKD
- Conditions
- Arterial Hypertension
- Keywords
- Arterial Hypertension, Resistant Arterial Hypertension, Chronic Kidney Disease, Fetuin A, DNLite IVD103
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hypertension, resistant hypertension, and secondary hypertension | – | Other: No intervention.Patients with arterial hypertension, resistant arterial hypertension, and secondary hypertension. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypertension and resistant hypertension followed-up in the Hypertension excellence centre and Lipid centre in University Hospital Ostrava.
Key inclusion criteria (1 listed)
- Arterial hypertension treated by at least one antihypertensive agent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention.No intervention. | Other | Patients with hypertension, resistant hypertension, and secondary hypertension |
Primary outcome
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.
3 secondary outcomes
Urine biomarker DNLite IVD103 - primary aim
Time frame: 1 year
Urine biomarker DNLite IVD103 - secondary aim
Time frame: 1 year
Urine biomarker DNLite IVD103 - correlation
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- The DNlite Test - Products - BIOPREVENTIVE MEDICINELink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zdeněk Ramík, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023; AzTrials last refreshed its copy on 26 Oct 2026.