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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,500
Medical Outpatient Department of the University Hospital Basel
Basel, Canton of Basel-City, Switzerland
Frequency of cardiovascular diseases
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
Time frame: At baseline, 6, 12 months and annually up to 10 years
Frequency of kidney diseases
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
Time frame: At baseline, 6, 12 months and annually up to 10 years
Frequency of liver diseases
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
Time frame: At baseline, 6, 12 months and annually up to 10 years
Frequency of metabolic diseases
Out of available clinical data from the local electronic health record the frequency of metabolic diseases (e.g. dyslipidemia, pre-/diabetes) will be assessed
Time frame: At baseline, 6, 12 months and annually up to 10 years
Frequency of microalbuminuria
Frequency of microalbuminuria
Time frame: At baseline, 6, 12 months and annually up to 5 years
Frequency of increased HbA1c
Frequency of increased HbA1c
Time frame: At baseline, 6, 12 months and annually up to 5 years
Assessment of Fib4-score
Assessment of Fib-4 score
Time frame: At baseline, 6, 12 months and annually up to 5 years
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Signs of hypertensive heart disease
Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH)
Time frame: At baseline, 6, 12 months and annually up to 10 years
Signs of steatosis hepatis
Signs of steatosis hepatis in abdominal sonography defined as increased liver echogenicity
Time frame: At baseline, 6, 12 months and annually up to 5 years
Structured, registry specific questionnaire
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.
Time frame: At baseline and annually up to 10 years
EQ-5D-5L
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.
Time frame: At baseline and annually up to 10 years