Chronic Kidney DiseaseNCT06083168
Cardiovascular Disease in Patients With Chronic Kidney Disease: Polish Kidney- Heart Project
An observational study of Chronic Kidney Disease and Cardiovascular Diseases, run by Medical University of Silesia at 2 sites in Poland.
Trial summary
This is an observational longitudinal study which will collect routine demographic, laboratory and clinical parameters of patients with chronic kidney disease (CKD) in the Silesian and Warmia and Mazury Regions (Poland) aimed at predicting incident cardiovascular disease and cardiovascular and renal events using… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Cardiovascular Diseases
- How many people
- 6,000 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Dec 2023to 31 Jan 2036
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in nephrology departments in Zabrze and Olsztyn.
Who may be able to join
- CKD defined as estimated glomerular filtration rate (eGFR) < 60ml/min/1.73 m2 and/or urine albumin creatinine ratio ( UACR) > 30 mg/g lasting at least 3 months
- CKD regardless of eGFR/albuminuria when documented otherwise (by means of imaging, renal biopsy result, genetic background, etc)
Who cannot join
- Death during hospital stay
- Terminal stage of cancer
- Lack of an informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tomasz Stompór, Prof. contact
Poland2 sites, 2 recruiting
- Recruiting
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561
Tomasz Stompór, Prof, 0048 89 538 6229, stompin@mp.pl
Tomasz Stompór, Prof.
- Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach
Zabrze, 41-800
Katarzyna Nabrdalik, assoc. Prof., 0048697592954, knabrdalik@sum.edu.pl
Hanna Kwiendacz, PhD, 0048509774849, hkwiendacz@sum.edu.pl
About this study
This is an observational longitudinal study which will collect routine demographic, laboratory and clinical parameters of patients with chronic kidney disease (CKD) in the Silesian and Warmia and Mazury Regions (Poland) aimed at predicting incident cardiovascular disease and cardiovascular and renal events using machine learning and artificial intelligence approaches. There will be a subgroup analysis of patients with diabetes and CKD.
Read the detailed description
This is a prospective, observational study seeking to collate demographic, laboratory, and clinical data from patients with CKD hospitalized at two academic centres: the Department of Internal Medicine, Diabetology and Nephrology in Zabrze, Silesia, and the Clinic of Nephrology, Hypertension and Internal Medicine in Olsztyn, Warmia and Mazury.
Patients will receive telephone check-ups annually post-discharge and will be proposed to attend on-site follow-up health checks. Patients will be followed up annually for 10 years or until death if occurs earlier, in order to collect information related to new onset cardiovascular events and progression to macroalbuminuria and/or doubling of serum creatinine with decrease of eGFR to less than 45 ml/min./1.73m2 (compared to baseline) or the onset of end stage renal disease (ESRD) or renal death. ESRD is defined as initiation of maintenance dialysis or kidney transplantation. All procedures, except eye fundus imaging for hospitalized patients align with standard nephrology ward care that patients agree for upon hospitalization.
The Medical University of Silesia and the University of Warmia and Mazury, Collegium Medicum obtained study approvals from the respective independent university- or chamber of physicians-based bioethics committees for performing fundus imaging during hospital stay and annual telephone contacts as well as on- site health checks for the longitudinal patient follow-up observation.
With patient consent, annual on-site visits will entail blood and urine assessments, ECG, retinal imaging via the fundus camera, and examinations for peripheral and cardiac autonomic neuropathy among those with diabetes. Biochemical analyses will focus on assessing serum creatinine, lipid profile, HbA1c for diabetic patients, and the urine albumin-creatinine ratio (UACR).
With a decade-long prospective follow-up focused on documenting new cardiovascular and renal events, the primary objective is to identify patients with CKD at the highest risk of cardiovascular disease and CKD progression. This goal will be achieved by implementing machine learning techniques to analyze clinical parameters that are easy to obtain in everyday clinical practice.
- Conditions
- Chronic Kidney Disease, Cardiovascular Diseases
- Keywords
- chronic kidney disease, cardiovascular disease, artificial inteligence, predictors
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Coronary Artery Disease
New occurrence of coronary artery disease as diagnosed by standard medical procedures.
Measured: Annually, 10 years from enrollment
Myocardial Infarction
New occurrence of myocardial infarction as confirmed by electrocardiogram and/or biomarkers.
Measured: Annually, 10 years from enrollment
New onset heart failure or exacerbation of heart failure
New-Onset Heart Failure: Diagnosis based on the ESC guidelines, which include symptoms such as breathlessness, ankle swelling, and fatigue; objective evidence of cardiac dysfunction or structural abnormality in echocardiography; and response to treatment directed towards heart failure.
Hospitalization for decompensated heart failure: Requires unscheduled admission to a healthcare facility with heart failure as the primary reason for admission.
Measured: Annually, 10 years from enrollment
Stroke or Transient Ischemic Attack
New occurrence of stroke as confirmed by neuroimaging or transient ischemic attack ascertained by typical symptoms.
Measured: Annually, 10 years from enrollment
Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease
New diagnosis of peripheral vascular disease confirmed by imaging studies.
Measured: Annually, 10 years from enrollment
Atrial Fibrillation
Incident atrial fibrillation confirmed by electrocardiogram.
Measured: Annually, 10 years from enrollment
Death Due to Cardiovascular Cause
Death where the primary cause is attributed to cardiovascular disease.
Measured: Annually, 10 years from enrollment
Progression of Chronic Kidney Disease
Progression to macroalbuminuria or doubling of serum creatinine with a decrease of eGFR to less than 45 ml/min/1.73m^2 compared to baseline.
Measured: Annually, 10 years from enrollment
End-Stage Renal Disease or Renal Death
Onset of end-stage renal disease requiring initiation of maintenance dialysis or kidney transplantation, or death due to renal causes.
Measured: Annually, 10 years from enrollment
Secondary outcomes (2)
Machine-learning predictors of outcomes, including ECG predictors and retinal imaging predictors.
Using new statistical methods in predicting outcomes
Measured: 10 years from enrollment
Cluster analyses.
Use of statistical cluster analysis to identify patterns within primary outcome measures.
Measured: 10 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Dec 2023
- Primary completion30 Nov 2033 (estimated)
- Study completion31 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warmia and Mazury in Olsztyn, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Katarzyna Nabrdalik, assoc. Prof, Principal investigator, Medical University of SilesiaTomasz Stompór, Prof., Principal investigator, The University of Warmia and Mazury in OlsztynGregory YH Lip, Prof., Study chair, University of LiverpoolJanusz Gumprecht, Prof., Study chair, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083168
- Sponsor's protocol ID
- Polish Kidney-Heart Project
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease in Patients With Chronic Kidney Disease: Polish Kidney- Heart Project
- ClinicalTrials.gov ID
- NCT06083168
- Acronym / sponsor ID
- Polish Kidney-Heart Project
- Conditions
- Chronic Kidney Disease, Cardiovascular Diseases
- Keywords
- chronic kidney disease, cardiovascular disease, artificial inteligence, predictors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- University of Warmia and Mazury in Olsztyn, University of Liverpool
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2033 (estimated)
- Study completion
- 31 Jan 2036 (estimated)
- First posted
- 13 Oct 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.
This is an observational longitudinal study which will collect routine demographic, laboratory and clinical parameters of patients with chronic kidney disease (CKD) in the Silesian and Warmia and Mazury Regions (Poland) aimed at predicting incident cardiovascular disease and cardiovascular and renal events using machine learning and artificial intelligence approaches. There will be a subgroup analysis of patients with diabetes and CKD.
Detailed description
This is a prospective, observational study seeking to collate demographic, laboratory, and clinical data from patients with CKD hospitalized at two academic centres: the Department of Internal Medicine, Diabetology and Nephrology in Zabrze, Silesia, and the Clinic of Nephrology, Hypertension and Internal Medicine in Olsztyn, Warmia and Mazury.
Patients will receive telephone check-ups annually post-discharge and will be proposed to attend on-site follow-up health checks. Patients will be followed up annually for 10 years or until death if occurs earlier, in order to collect information related to new onset cardiovascular events and progression to macroalbuminuria and/or doubling of serum creatinine with decrease of eGFR to less than 45 ml/min./1.73m2 (compared to baseline) or the onset of end stage renal disease (ESRD) or renal death. ESRD is defined as initiation of maintenance dialysis or kidney transplantation. All procedures, except eye fundus imaging for hospitalized patients align with standard nephrology ward care that patients agree for upon hospitalization.
The Medical University of Silesia and the University of Warmia and Mazury, Collegium Medicum obtained study approvals from the respective independent university- or chamber of physicians-based bioethics committees for performing fundus imaging during hospital stay and annual telephone contacts as well as on- site health checks for the longitudinal patient follow-up observation.
With patient consent, annual on-site visits will entail blood and urine assessments, ECG, retinal imaging via the fundus camera, and examinations for peripheral and cardiac autonomic neuropathy among those with diabetes. Biochemical analyses will focus on assessing serum creatinine, lipid profile, HbA1c for diabetic patients, and the urine albumin-creatinine ratio (UACR).
With a decade-long prospective follow-up focused on documenting new cardiovascular and renal events, the primary objective is to identify patients with CKD at the highest risk of cardiovascular disease and CKD progression. This goal will be achieved by implementing machine learning techniques to analyze clinical parameters that are easy to obtain in everyday clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in nephrology departments in Zabrze and Olsztyn.
Key inclusion criteria (2 listed)
- CKD defined as estimated glomerular filtration rate (eGFR) < 60ml/min/1.73 m2 and/or urine albumin creatinine ratio ( UACR) > 30 mg/g lasting at least 3 months
- CKD regardless of eGFR/albuminuria when documented otherwise (by means of imaging, renal biopsy result, genetic background, etc)
Key exclusion criteria (3 listed)
- Death during hospital stay
- Terminal stage of cancer
- Lack of an informed consent
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
Incident Coronary Artery Disease
Time frame: Annually, 10 years from enrollment
New occurrence of coronary artery disease as diagnosed by standard medical procedures.
Myocardial Infarction
Time frame: Annually, 10 years from enrollment
New occurrence of myocardial infarction as confirmed by electrocardiogram and/or biomarkers.
New onset heart failure or exacerbation of heart failure
Time frame: Annually, 10 years from enrollment
New-Onset Heart Failure: Diagnosis based on the ESC guidelines, which include symptoms such as breathlessness, ankle swelling, and fatigue; objective evidence of cardiac dysfunction or structural abnormality in echocardiography; and response to treatment directed towards heart failure. Hospitalization for decompensated heart failure: Requires unscheduled admission to a healthcare facility with heart failure as the primary reason for admission.
Stroke or Transient Ischemic Attack
Time frame: Annually, 10 years from enrollment
New occurrence of stroke as confirmed by neuroimaging or transient ischemic attack ascertained by typical symptoms.
Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease Peripheral Vascular Disease
Time frame: Annually, 10 years from enrollment
New diagnosis of peripheral vascular disease confirmed by imaging studies.
Atrial Fibrillation
Time frame: Annually, 10 years from enrollment
Incident atrial fibrillation confirmed by electrocardiogram.
Death Due to Cardiovascular Cause
Time frame: Annually, 10 years from enrollment
Death where the primary cause is attributed to cardiovascular disease.
Progression of Chronic Kidney Disease
Time frame: Annually, 10 years from enrollment
Progression to macroalbuminuria or doubling of serum creatinine with a decrease of eGFR to less than 45 ml/min/1.73m^2 compared to baseline.
End-Stage Renal Disease or Renal Death
Time frame: Annually, 10 years from enrollment
Onset of end-stage renal disease requiring initiation of maintenance dialysis or kidney transplantation, or death due to renal causes.
2 secondary outcomes
Machine-learning predictors of outcomes, including ECG predictors and retinal imaging predictors.
Time frame: 10 years from enrollment
Cluster analyses.
Time frame: 10 years from enrollment
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 2 May 2024.
- Individual participant dataSharing planned: No
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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.
Tomasz Stompór, Prof. contact
Katarzyna Nabrdalik, assoc. Prof principal investigator
Medical University of Silesia
Tomasz Stompór, Prof. principal investigator
The University of Warmia and Mazury in Olsztyn
Gregory YH Lip, Prof. study chair
University of Liverpool
2 sites 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 Disease and Cardiovascular Diseases, run by Medical University of Silesia at 2 sites in Poland.
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 2 inclusion and 3 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 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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 Katarzyna Nabrdalik, assoc. Prof (0048323704438, knabrdalik@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident Coronary Artery Disease (time frame: Annually, 10 years from enrollment). The study lists 9 primary outcomes in all. 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 2 May 2024.