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NCT Number: NCT06083168

Cardiovascular Disease in Patients With Chronic Kidney Disease: Polish Kidney- Heart Project

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wojewódzki Szpital Specjalistyczny w Olsztynie, Olsztyn, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Death during hospital stay
  • Terminal stage of cancer
  • Lack of an informed consent

Treatment and study plan

Primary outcomes

  1. Incident Coronary Artery Disease

    Time frame: Annually, 10 years from enrollment

    New occurrence of coronary artery disease as diagnosed by standard medical procedures.

  2. Myocardial Infarction

    Time frame: Annually, 10 years from enrollment

    New occurrence of myocardial infarction as confirmed by electrocardiogram and/or biomarkers.

  3. 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.

  4. 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.

  5. 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.

  6. Atrial Fibrillation

    Time frame: Annually, 10 years from enrollment

    Incident atrial fibrillation confirmed by electrocardiogram.

  7. Death Due to Cardiovascular Cause

    Time frame: Annually, 10 years from enrollment

    Death where the primary cause is attributed to cardiovascular disease.

  8. 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.

  9. 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.

Secondary outcomes

  1. Machine-learning predictors of outcomes, including ECG predictors and retinal imaging predictors.

    Time frame: 10 years from enrollment

    Using new statistical methods in predicting outcomes

  2. Cluster analyses.

    Time frame: 10 years from enrollment

    Use of statistical cluster analysis to identify patterns within primary outcome measures.

Study contacts

Contact information is provided by the study sponsor or research team.

Katarzyna Nabrdalik, assoc. Prof

CONTACT

[email protected]

0048323704438

Tomasz Stompór, Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • University of Liverpool
  • University of Warmia and Mazury in Olsztyn

Registry information

Important dates

Study start
2023
Primary completion
2033
Study completion
2036
First posted
Oct 13, 2023
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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