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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
prevalence of significant asymptomatic cardiac structural abnormalities and cardiac dysfunction
时间窗: 1 year
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.
Proteomic analysis
时间窗: 1 year
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
次要结局
- 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)
研究者
Univ.-Prof. Dr. med. Frank Edelmann
Prof. Dr. med. Frank Edelmann
Charite University, Berlin, Germany