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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083168
• Other study ID #: Polish Kidney-Heart Project
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: January 31, 2036

Study information

• Verified date: September 2023
• Source: Medical University of Silesia
• Contact: Katarzyna Nabrdalik, assoc. Prof
• Phone: 0048323704438
• Email: knabrdalik[@]sum.edu.pl
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: January 31, 2036
• Est. primary completion date: November 30, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Poland	Wojewódzki Szpital Specjalistyczny w Olsztynie	Olsztyn
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 im. prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach	Zabrze

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Silesia	University of Liverpool, University of Warmia and Mazury in Olsztyn

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident Coronary Artery Disease	New occurrence of coronary artery disease as diagnosed by standard medical procedures.	Annually, 10 years from enrollment
Primary	Myocardial Infarction	New occurrence of myocardial infarction as confirmed by electrocardiogram and/or biomarkers.	Annually, 10 years from enrollment
Primary	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
Primary	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
Primary	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
Primary	Atrial Fibrillation	Incident atrial fibrillation confirmed by electrocardiogram.	Annually, 10 years from enrollment
Primary	Death Due to Cardiovascular Cause	Death where the primary cause is attributed to cardiovascular disease.	Annually, 10 years from enrollment
Primary	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
Primary	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	Machine-learning predictors of outcomes, including ECG predictors and retinal imaging predictors.	Using new statistical methods in predicting outcomes	10 years from enrollment
Secondary	Cluster analyses.	Use of statistical cluster analysis to identify patterns within primary outcome measures.	10 years from enrollment