Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Signs of hypertensive heart disease
研究概览
简要总结
The aim of this clinical and exploratory Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry is to establish high quality prevalence and incidence database for Cardiovascular-Kidney-Metabolic (CKM) syndrome, its major contributors, and the extent of the respective organ damaged.
详细描述
The Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry is a prospective, longitudinal, non-interventional registry based at the Medical Outpatient Department of the University Hospital Basel. It aims to address key knowledge gaps related to (I) the prevalence, incidence, and heterogeneity of CKLM syndrome and its clinical phenotypes, (II) liver involvement, (III) emerging therapies, and (IV) the need for interdisciplinary care and integrated management. The registry supports improved understanding and management of this complex syndrome in routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Individuals diagnosed with cardiovascular-kidney-metabolic (CKM) syndrome stages 0 to 3 according to the American Heart Association (AHA) or liver disease defined by any of the following:
- •For stage 0: Individuals without overweight/obesity, metabolic risk factors (normoglycemia, normotension, normal lipid profile), Chronic kidney disease (CKD), or Cardiovascular disease (CVD)
- •Individuals with overweight/obesity or dysfunctional adipose tissue, without other metabolic risk factors or CKD
- •Individuals with metabolic risk factors (hypertriglyceridemia, arterial hypertension, metabolic syndrome, diabetes) or CKD
- •Subclinical Atherosclerotic cardiovascular disease (ASCVD) or subclinical heart failure (HF) in individuals with excess/dysfunctional adiposity, other metabolic risk factors, or CKD in the clinical assessment[2]
- •Independent of CKM syndrome stages, individual with signs of hepatic steatosis on imaging
- •Willingness to provide informed consent
排除标准
- •Individuals with CKM syndrome stage 4 according to the AHA
- •* Individuals with clinical cardiovascular disease including:
- •History of coronary artery disease, myocardial infarction, coronary artery intervention
- •History of atrial fibrillation
- •History of stroke
- •Symptomatic peripheral artery disease (>stage I)
- •History of symptomatic HF
- •History of HF hospitalisation
- •Inability to sign informed consent
结局指标
主要结局
Signs of hypertensive heart disease
时间窗: At baseline, 6, 12 months and annually up to 10 years
Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH)
Frequency of cardiovascular diseases
时间窗: At baseline, 6, 12 months and annually up to 10 years
Out of available clinical data from the local electronic health record the frequency of cardiovascular diseases (e.g. stroke, myocardial infarction, coronary artery disease, peripheral arterial disease, hypertension, heart failure) will be assessed
Frequency of metabolic diseases
时间窗: At baseline, 6, 12 months and annually up to 10 years
Out of available clinical data from the local electronic health record the frequency of metabolic diseases (e.g. dyslipidemia, pre-/diabetes) will be assessed
Frequency of kidney diseases
时间窗: At baseline, 6, 12 months and annually up to 10 years
Out of available clinical data from the local electronic health record the frequency of kidney diseases (e.g. chronic kidney disease, kidney failure) will be assessed
Frequency of microalbuminuria
时间窗: At baseline, 6, 12 months and annually up to 5 years
Frequency of microalbuminuria
Assessment of Fib4-score
时间窗: At baseline, 6, 12 months and annually up to 5 years
Assessment of Fib-4 score
Structured, registry specific questionnaire
时间窗: At baseline and annually up to 10 years
The structured questionnaire is register-specifically designed and focuses on questions related to health behavior, medical history, mental health disorders, social determinants of health and adverse events. The collected data are aggregated to allow for standardized evaluation of key domains across the study population.
Frequency of liver diseases
时间窗: At baseline, 6, 12 months and annually up to 10 years
Out of available clinical data from the local electronic health record the frequency of liver diseases (e.g. Metabolic Dysfunction-associated steatotic liver disease, MASLD) will be assessed
Frequency of increased HbA1c
时间窗: At baseline, 6, 12 months and annually up to 5 years
Frequency of increased HbA1c
Signs of steatosis hepatis
时间窗: At baseline, 6, 12 months and annually up to 5 years
Signs of steatosis hepatis in abdominal sonography defined as increased liver echogenicity
EQ-5D-5L
时间窗: At baseline and annually up to 10 years
Assessment of quality of life with the EQ-5D-5L ( (European Quality of Life 5 Dimensions 5 Level Version) tool within the study specific questionaire. 5 Dimensions of quality of life will be asked and coded in a 1-digit number that describes health state. Higher 1-digit numbers indicate a worse outcome. The tool also includes a EQ visual analogue scale (VAS), a quantitative and subjective measure of health outcome. Higher values indicate a better outcome.
次要结局
未报告次要终点