Screen CardRen - A Cross-sectional Observational Cohort Study
Recruiting · NCT06272578 · Observational (researchers observe without assigning treatment) · Lead sponsor: Charite University, Berlin, Germany
View the official record on ClinicalTrials.gov →Interventions studied
Echocardiography
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed.
- German Heart Center Charité (DHZC) - Wedding, State of Berlin, Germany