NCT06272578

Screen CardRen - A Cross-sectional Observational Cohort Study

A Cross-sectional Observational Cohort Study to Evaluate the Prevalence of Asymptomatic Cardiac Structural Abnormalities and Cardiac Dysfunction in a Contemporary Outpatient at Risk Population With Chronic Kidney Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this single-centre, cross-sectional study, the investigators aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes.The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure.

Detailed description

Background/Rationale: Chronic kidney disease and cardiovascular disease share a large set of risk factors, such as arterial hypertension, type 2 diabetes mellitus and dyslipidaemia. Chronic kidney disease, even in early stages, further increases the risk for cardiovascular diseases such as heart failure. Objectives and Hypotheses: In this single-centre, cross-sectional study, the investigators will aim to assess the prevalence of asymptomatic echocardiographic structural and functional cardiac abnormalities in adult CKD patients with additional cardiovascular risk factors. Furthermore, with the use of Olink technology, analyses of the plasma proteome will be performed to identify potential protein pathways associated with early structural changes. The investigators hypothesize that protein expression will be altered in patients with prevalent echocardiographic abnormalities that indicate stage B heart failure. Methods: Study design: single-centre, cross-sectional, non-interventional study Data Source(s): electronic case report form containing patient history, clinical status and physical examination, imaging data from echocardiography, air displacement plethysmography data, plasma proteome data obtained from Olink technology-based analysis of blood samples Study Population: Adult chronic kidney disease patients with additional cardiovascular risk factors (at least one of the following: arterial hypertension, type 2 diabetes mellitus, and dyslipidaemia). The inclusion criteria are further defined in the corresponding section of the study protocol. Exposure(s): chronic kidney disease and cardiovascular risk factors such as arterial hypertension, type 2 diabetes mellitus, dyslipidaemia, or atherosclerotic vascular disease Outcome(s): Primary objective: • Assess the frequency of stage B heart failure as indicated by structural or functional cardiac abnormalities assessed by echocardiography and/or corresponding laboratory parameters Secondary objectives: * Identification of possible predictive parameters for significant cardiac dysfunction (Heart Failure Stage B) in a contemporary at risk cohort with renal dysfunction, based on imaging and proteomics data * Building of the Berlin-Brandenburg prevention network to improve the intersectional cooperation to identify, diagnose and follow-up risk patients * Establishment of tools like US.2 AI, electronic health records, central data management in order to enable a fast construction while working resource-friendly * Follow-up of risk patients based on mobile sensors/apps * Adoption of screening in standard care Sample Size Estimations: The study is focused on the estimation of the prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction in a contemporary at risk cohort with chronic kidney disease. Therefore, the investigators will calculate the corresponding two-sided 95% confidence interval. With a sample size of 400 patients, a two-sided 95% confidence interval for an assumed prevalence of 30% can be determined with an extension of ± 4%. Statistical Analysis: Objectives will be analyzed according to their scaling and distribution characteristics, including appropriate descriptive location and variability parameters and 95% confidence intervals. Additionally, multiple regression analyses will be performed in order to identify potential risk factors for significant cardiac dysfunction.

Conditions

• Heart Failure
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiography	Echocardiography

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-02-27
• Completion: 2025-06-30
• First posted: 2024-02-22
• Last updated: 2024-08-21

Locations

1 site across 1 country: Germany