Chronic Kidney FailureHORUZNCT06987032
Hemodynamics in Chronic Kidney Disease
An observational study of Chronic Kidney Failure, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
The goal of this observational study is to learn about the role of thoracic and whole body bioimpedance in the hemodynamic profile of patients with chronic kidney disease. The main question it aims to answer is: Is bioimpedance-determined fluid status associated with kidney function decline in patients with chronic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Failure
- How many people
- 71 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jan 2021to 9 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 206 patients with CKD stages 3-5 will be included from the outpatient clinic of Ziekenhuis Zuid-Oost Limburg in Genk (Belgium). A healthy control group for the cross-sectional part will be recruited through visitors and/or personnel of Ziekenhuis Oost-Limburg in Genk (Belgium).
Who may be able to join
- Prevalent non-dialysis patients with estimated glomerular filtration rate < 60 ml/min (for chronic kidney disease subjects)
- Age > 18 years
- Signed informed consent
Who cannot join
- Acute kidney injury
- estimated glomerular filtration rate < 20ml/min directly post-nephrectomy
- Clinical conditions affecting bioimpedance measurements: limb amputation, impaired skin integrity, brain stimulator, pacemaker with low threshold or unipolar pacemaker.
- Clinical conditions affecting body composition: liver cirrhosis, active infectious disease or any acute cardiovascular event (defined as cerebrovascular event, myocard infarction, heart failure) during the 3 months before screening for inclusion
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Hemodynamic Profile Of Chronic Renal Patients by Use of Bioimpedance
The goal of this observational study is to learn about the role of thoracic and whole body bioimpedance in the hemodynamic profile of patients with chronic kidney disease.
The main question it aims to answer is:
- Is bioimpedance-determined fluid status associated with kidney function decline in patients with chronic kidney disease stage 3 - 5 (non dialysis).
Read the detailed description
Participants will be measured during their regular visit to their treating nephrologist.
During a follow up of one year, 3 or 4 visits will be scheduled.
- Bioimpedance and blood pressure measurements will be achieved by non-invasive techniques.
- Blood sampling will as much as possible coincide with regular blood samplings for clinical purposes.
- All subjects will undergo echocardiography at baseline and after one year follow up.
- Conditions
- Chronic Kidney Failure
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
whole body fluid status
The primary objective is to associate the bioimpedance-determined fluid status [fluid overload versus non-fluid overload] with kidney function decline in patients with chronic kidney disease stage 3 (59-30ml/min), 4 (29-15ml/min) and 5 (< 15 ml/min).
Measured: Baseline, every 3 months during 1 year
Secondary outcomes (1)
identify the clinical factors associated with fluid overload during a longitudinal follow up
Secondary outcomes of interest are the central volume status (measured as ejection fraction in % by echocardiography and thoracic bioimpedance in Ohms in combination with photoplethysmography), the cardiac systolic and diastolic function (measured by echocardiography), cardiovascular events, hospitalizations, inflammatory- and nutrition status (by whole body bioimpedance measurements), and quality of life (by Short Form 36 questionnaire).
Measured: Baseline, every 3 months during 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start9 Jan 2021
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pieter Vandervoort, PhD, Principal investigator, University Hasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987032
- Sponsor's protocol ID
- ctu2019039
- Acronym
- HORUZ
- Status last verified
- Jan 2021
- First submitted
- 21 Mar 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Hemodynamic Profile Of Chronic Renal Patients by Use of Bioimpedance
- ClinicalTrials.gov ID
- NCT06987032
- Acronym / sponsor ID
- HORUZ / ctu2019039
- Conditions
- Chronic Kidney Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 23 May 2025 (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.
The goal of this observational study is to learn about the role of thoracic and whole body bioimpedance in the hemodynamic profile of patients with chronic kidney disease.
The main question it aims to answer is:
- Is bioimpedance-determined fluid status associated with kidney function decline in patients with chronic kidney disease stage 3 - 5 (non dialysis).
Detailed description
Participants will be measured during their regular visit to their treating nephrologist.
During a follow up of one year, 3 or 4 visits will be scheduled.
- Bioimpedance and blood pressure measurements will be achieved by non-invasive techniques.
- Blood sampling will as much as possible coincide with regular blood samplings for clinical purposes.
- All subjects will undergo echocardiography at baseline and after one year follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 206 patients with CKD stages 3-5 will be included from the outpatient clinic of Ziekenhuis Zuid-Oost Limburg in Genk (Belgium). A healthy control group for the cross-sectional part will be recruited through visitors and/or personnel of Ziekenhuis Oost-Limburg in Genk (Belgium).
Key inclusion criteria (3 listed)
- Prevalent non-dialysis patients with estimated glomerular filtration rate < 60 ml/min (for chronic kidney disease subjects)
- Age > 18 years
- Signed informed consent
Key exclusion criteria (5 listed)
- Acute kidney injury
- estimated glomerular filtration rate < 20ml/min directly post-nephrectomy
- Clinical conditions affecting bioimpedance measurements: limb amputation, impaired skin integrity, brain stimulator, pacemaker with low threshold or unipolar pacemaker.
- Clinical conditions affecting body composition: liver cirrhosis, active infectious disease or any acute cardiovascular event (defined as cerebrovascular event, myocard infarction, heart failure) during the 3 months before screening for inclusion
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
whole body fluid status
Time frame: Baseline, every 3 months during 1 year
The primary objective is to associate the bioimpedance-determined fluid status [fluid overload versus non-fluid overload] with kidney function decline in patients with chronic kidney disease stage 3 (59-30ml/min), 4 (29-15ml/min) and 5 (< 15 ml/min).
1 secondary outcome
identify the clinical factors associated with fluid overload during a longitudinal follow up
Time frame: Baseline, every 3 months during 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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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. This study is not recruiting at the moment.
Pieter Vandervoort, PhD principal investigator
University Hasselt
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 Chronic Kidney Failure, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 23 May 2025. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whole body fluid status (time frame: Baseline, every 3 months during 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 23 May 2025.