Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cradiovascular-kidney-liver-metabolic (CKLM) Syndrome, Cardiovascular-kidney-metabolic Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Frequency of cardiovascular diseases [Time frame: At baseline, 6, 12 months and annually up to 10 years]
- Frequency of kidney diseases [Time frame: At baseline, 6, 12 months and annually up to 10 years]
- Frequency of liver diseases [Time frame: At baseline, 6, 12 months and annually up to 10 years]
- Frequency of metabolic diseases [Time frame: At baseline, 6, 12 months and annually up to 10 years]
- Frequency of microalbuminuria [Time frame: At baseline, 6, 12 months and annually up to 5 years]
- Frequency of increased HbA1c [Time frame: At baseline, 6, 12 months and annually up to 5 years]
- Assessment of Fib4-score [Time frame: At baseline, 6, 12 months and annually up to 5 years]
- Signs of hypertensive heart disease [Time frame: At baseline, 6, 12 months and annually up to 10 years]
- Signs of steatosis hepatis [Time frame: At baseline, 6, 12 months and annually up to 5 years]
- Structured, registry specific questionnaire [Time frame: At baseline and annually up to 10 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Medical Outpatient Department of the University Hospital Basel — Basel
Identifiers
NCT: NCT07084688 · 2025-00756; am25Vischer