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NCT Number: NCT07084688

Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry

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.

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Key information

Conditions

Cradiovascular-kidney-liver-metabolic (CKLM) Syndrome Cardiovascular Diseases Cardiovascular-kidney-metabolic Syndrome Chronic Disease Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Outpatient Department of the University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location contact

Annina Vischer, PD Dr. med.

CONTACT

[email protected]

0041613286630

Annina Vischer, PD Dr. med.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of cardiovascular diseases

    Time frame: 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

  2. Frequency of kidney diseases

    Time frame: 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

  3. Frequency of liver diseases

    Time frame: 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

  4. Frequency of metabolic diseases

    Time frame: 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

  5. Frequency of microalbuminuria

    Time frame: At baseline, 6, 12 months and annually up to 5 years

    Frequency of microalbuminuria

  6. Frequency of increased HbA1c

    Time frame: At baseline, 6, 12 months and annually up to 5 years

    Frequency of increased HbA1c

  7. Assessment of Fib4-score

    Time frame: At baseline, 6, 12 months and annually up to 5 years

    Assessment of Fib-4 score

  8. Signs of hypertensive heart disease

    Time frame: 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)

  9. Signs of steatosis hepatis

    Time frame: At baseline, 6, 12 months and annually up to 5 years

    Signs of steatosis hepatis in abdominal sonography defined as increased liver echogenicity

  10. Structured, registry specific questionnaire

    Time frame: 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.

  11. EQ-5D-5L

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annina Vischer, PD Dr. med.

CONTACT

[email protected]

0041613286630

Thilo Burkard, PD Dr. med.

CONTACT

[email protected]

0041613287738

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2025
Primary completion
2040
Study completion
2040
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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