Screen CardRen - A Cross-sectional Observational Cohort Study

NCT06272578 | Recruiting

• 1 other identifier: 20021405
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction

  Transthoracic echocardiographic measurements are the primary outcome parameters and will be conducted according to the current recommendations for cardiac chamber quantification of the American Society of Echocardiography and the European Association of Cardiovascular Imaging, the latest update on left ventricular diastolic function assessment and recommendations on aortic stenosis quantification.

  1 year

• Proteomic analysis

  Proteomic analysis will be performed using Olink technology, which is based on proximity extension assay (PEA) technology combined with next generation sequencing. This method has demonstrated accuracy and sensitivity in detecting minute quantities of proteins (sub-pg/ml), making it suitable for conducting extensive multiplex assays covering a wide dynamic range. In this study, plasma samples

  1 year

Secondary Outcomes (3)

• Duration of echocardiographic examination

  1 year

• Time saved by portable echocardiography and automated image analysis

  1 year

• Image quality of cart-based vs. portable echo images

  1 year

Interventions

Echocardiography DIAGNOSTIC_TEST

Echocardiography

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

The study population will comprise 400 adult patients with chronic kidney disease, defined as elevated urine albumin to creatinine ratio (UACR \> 30 mg/g or \>3 mg/mmol) or reduced estimated glomerular filtration rate (eGFR \< 60 ml/min/1.73m²) at a one-time measurement. In addition to renal function impairment, study participants will either have a background of cardiovascular risk factors, including arterial hypertension, type 2 diabetes mellitus or hypercholesterolemia.

You may qualify if:

• Chronic Kidney Disease, stages G1-G4, AND
• Estimated glomerular filtration rate (eGFR) as determined by the 2009 CKD-EPI Cr equation ≥ 60 ml/min/1.73m², if UACR ≥30 mg/g (≥3 mg/mmol) OR
• eGFR according to CKD-EPI 2009 Cr equation \< 60 ml/min/1.73m², but \> 15 ml/min/1.73m²
• Diabetes mellitus type 2 OR
• Pathological findings in oral glucose tolerance test (≥ 200 mg/dl (2h)) OR
• documented HbA1c ≥ 6.5 % OR
• Intake of any antidiabetic medication (in case of previously established diagnosis of Diabetes mellitus type 2) OR
• Fasting blood glucose ≥ 126 mg/dl
• Arterial Hypertension Grade ≥ 1 OR
• Blood pressure of ≥ 140/90 mmHg, defined according to the 2018 ESC guidelines on arterial hypertension (Williams) OR
• Intake of antihypertensive drugs
• Hypercholesterolemia OR
• LDL-cholesterol \> 130mg/dl OR
• Intake of a lipid-lowering medication initiated to treat dyslipoptroteinemia

You may not qualify if:

• History of acute kidney injury \> stage 1 according to KDIGO criteria in the two weeks prior to study visit
• Chronic kidney disease Stage 5 (end-stage renal disease)
• Previous diagnosis of chronic heart failure
• Acute myocardial infarction in the past 30 days prior to study visit
• Stroke in the past 30 days prior to study visit
• Known congenital heart disease
• Previous diagnosis of a specific cardiomyopathy, infiltrative cardiac disease, pericardial constriction, sarcoidosis, amyloidosis and other storage diseases
• Implanted cardiac devices, such as pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices
• Implanted mechanical valve prosthesis
• Inability to give informed consent
• Lack of health insurance
• Organ transplanted
• Intake of immunosuppressive medication
• Major surgery in the 6 months before study visit, such as cardiac bypass surgery or valve replacement surgery (thoracotomy), major vascular surgery (such as replacement of aortic root, ascending part, aortic arch or any part of the abdominal aorta), major abdominal surgery (e.g. Whipple procedure, colorectal resection, gastrectomy and others) or limb amputation

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• AstraZeneca: collaborator

Study Sites (1)

German Heart Center Charité (DHZC)

Wedding, State of Berlin, 13353, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fasting blood samples will be collected preferably from a cubital vein or any other vein of the upper extremity, if cubital veins are not accessible. The collected blood volume will comprise 12 ml for local baseline laboratory and another 12 ml for processing and storage for proteomic analyses. Biomaterial will be collected at single study visit for all participants and stored as frozen samples (-80°C) at the central biobanking facility (Zebanc) of Charité Campus Virchow Klinikum after immediate processing. Proteome measurement and analysis will be performed only after study enrolment has been closed.

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency, Chronic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; 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

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Frank Edelmann, Prof. Dr.

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Zurkan

CONTACT

+49 30 450 665 374; daniela.zurkan@dhzc-charite.de

Friederike Fenske

CONTACT

+49 30 450 653 782; friederike.fenske@dhzc-charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Frank Edelmann

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: February 22, 2024
• Study Start: March 1, 2024
• Primary Completion: February 27, 2025
• Study Completion: June 30, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)