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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Chronic Kidney Disease

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 Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Katarzyna Nabrdalik, assoc. Prof; Phone Number: 0048323704438; Email: knabrdalik@sum.edu.pl
• Study Contact Backup: Name: Tomasz Stompór, Prof.; Email: stompin@mp.pl

Study Locations

• Poland
  • Olsztyn, Poland, 10-561
    • Recruiting
    • Wojewodzki Szpital Specjalistyczny w Olsztynie
    • Contact: Tomasz Stompór, Prof; Phone Number: 0048 89 538 6229; Email: stompin@mp.pl
    • Principal Investigator: Tomasz Stompór, Prof.
    • Sub-Investigator: Paulina Dziamałek - Macioszczyk
    • Sub-Investigator: Agata Winiarska, PhD
    • Sub-Investigator: Zuzanna Smuniewska
    • Sub-Investigator: Tomasz Maroszczuk
    • Sub-Investigator: Janusz Pieczyński
  • Zabrze, Poland, 41-800
    • Recruiting
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach
    • Contact: Hanna Kwiendacz, PhD; Phone Number: 0048509774849; Email: hkwiendacz@sum.edu.pl
    • Contact: Katarzyna Nabrdalik, assoc. Prof.; Phone Number: 0048697592954; Email: knabrdalik@sum.edu.pl
    • Principal Investigator: Katarzyna Nabrdalik, assoc. Prof
    • Sub-Investigator: Janusz Gumprecht, Prof
    • Sub-Investigator: Hanna Kwiendacz, PhD
    • Sub-Investigator: Krzysztof Irlik
    • Sub-Investigator: Mirela Hendel
    • Sub-Investigator: Julia Piaśnik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in nephrology departments in Zabrze and Olsztyn.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident Coronary Artery Disease	New occurrence of coronary artery disease as diagnosed by standard medical procedures.	Annually, 10 years from enrollment
Myocardial Infarction	New occurrence of myocardial infarction as confirmed by electrocardiogram and/or biomarkers.	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.	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.	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.	Annually, 10 years from enrollment
Atrial Fibrillation	Incident atrial fibrillation confirmed by electrocardiogram.	Annually, 10 years from enrollment
Death Due to Cardiovascular Cause	Death where the primary cause is attributed to cardiovascular disease.	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.	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.	Annually, 10 years from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Machine-learning predictors of outcomes, including ECG predictors and retinal imaging predictors.	Using new statistical methods in predicting outcomes	10 years from enrollment
Cluster analyses.	Use of statistical cluster analysis to identify patterns within primary outcome measures.	10 years from enrollment

Collaborators and Investigators

• Sponsor: Medical University of Silesia
• Collaborators: University of Liverpool; University of Warmia and Mazury in Olsztyn
• Investigators: Principal Investigator: Katarzyna Nabrdalik, assoc. Prof, Medical University of Silesia; Principal Investigator: Tomasz Stompór, Prof., The University of Warmia and Mazury in Olsztyn; Study Chair: Gregory YH Lip, Prof., University of Liverpool; Study Chair: Janusz Gumprecht, Prof., Medical University of Silesia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): November 30, 2033
• Study Completion (Estimated): January 31, 2036

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular disease; chronic kidney disease; predictors; artificial inteligence
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Polish Kidney-Heart Project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No