Assessing heart and kidney health in patients with chronic kidney disease
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
This study is trying to see if people with chronic kidney disease and heart risk factors have hidden heart problems that can be detected through blood tests and heart scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Wedding, State of Berlin) |
| Trial ID | NCT06272578 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence of asymptomatic echocardiographic abnormalities in adults with chronic kidney disease (CKD) who also have cardiovascular risk factors. By utilizing advanced Olink technology, the study will analyze plasma proteome data to identify protein pathways linked to early structural changes in the heart. The research will involve collecting patient history, clinical data, and imaging results from echocardiography to understand the relationship between CKD and heart failure. The findings may provide insights into the early detection of heart issues in CKD patients.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic kidney disease stages G1-G4 who also have at least one cardiovascular risk factor such as hypertension, type 2 diabetes, or dyslipidemia.
Not a fit: Patients with a history of acute kidney injury greater than stage 1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of heart failure in patients with chronic kidney disease.
How similar studies have performed: Other studies have shown success in identifying cardiovascular risks in CKD patients, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wedding, State of Berlin
- German Heart Center Charité (DHZC) — Wedding, State of Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Frank Edelmann, Prof. Dr. — German Heart Institute
- Study coordinator: Daniela Zurkan
- Email: daniela.zurkan@dhzc-charite.de
- Phone: +49 30 450 665 374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.