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

NCT06083168 | Recruiting

• 1 other identifier: Polish Kidney-Heart Project
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 2

Brief 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 machine learning and artificial intelligence approaches. There will be a subgroup analysis of patients with diabetes and CKD.

Conditions

Chronic Kidney Disease; Cardiovascular Diseases

Keywords

chronic kidney disease; cardiovascular disease; artificial inteligence; predictors

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

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

  10 years from enrollment

• Cluster analyses.

  10 years from enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in nephrology departments in Zabrze and Olsztyn.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Silesia: lead
• University of Warmia and Mazury in Olsztyn: collaborator
• University of Liverpool: collaborator

Study Sites (2)

Wojewódzki Szpital Specjalistyczny w Olsztynie

Olsztyn, 10-561, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach

Zabrze, 41-800, Poland

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katarzyna Nabrdalik, assoc. Prof

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

• Tomasz Stompór, Prof.

  The University of Warmia and Mazury in Olsztyn

  PRINCIPAL INVESTIGATOR

• Gregory YH Lip, Prof.

  University of Liverpool

  STUDY CHAIR

• Janusz Gumprecht, Prof.

  Medical University of Silesia

  STUDY CHAIR

Central Study Contacts

Katarzyna Nabrdalik, assoc. Prof

CONTACT

0048323704438; knabrdalik@sum.edu.pl

Tomasz Stompór, Prof.

CONTACT

stompin@mp.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 13, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): November 30, 2033
• Study Completion (Estimated): January 31, 2036
• Last Updated: May 2, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)