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

NCT07084688 | Not Yet Recruiting

• 1 other identifier: 2025-00756; am25Vischer
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cradiovascular-kidney-liver-metabolic (CKLM) Syndrome; Cardiovascular-kidney-metabolic Syndrome

Keywords

Cardiovascular-kidney-liver-metabolic (CKLM) syndrome; Cardiovascular disease (CVD); Chronic kidney disease (CKD); Organ-specific diseases; Cardiovascular-kidney-metabolic (CKM) syndrome

Outcome Measures

Primary Outcomes (11)

• 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

  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

  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

  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

  At baseline, 6, 12 months and annually up to 10 years

• Frequency of microalbuminuria

  Frequency of microalbuminuria

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

• Frequency of increased HbA1c

  Frequency of increased HbA1c

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

• Assessment of Fib4-score

  Assessment of Fib-4 score

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

• Signs of hypertensive heart disease

  Signs of hypertensive heart disease at transthoracic echocardiography determined by left ventricular hypertrophy (LVH)

  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

  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.

  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.

  At baseline and annually up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 200-300 participants with cardiovascular-kidney-metabolic (CKM) syndrome per year at the Medical Outpatient Department of the University Hospital Basel

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Medical Outpatient Department of the University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Syndrome; Cardiovascular Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Officials

• Annina Vischer, PD Dr. med.

  Medical Outpatient Department and Hypertension Clinic, ESH Hypertension Centre of Excellence, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annina Vischer, PD Dr. med.

CONTACT

0041613286630; annina.vischer@usb.ch

Thilo Burkard, PD Dr. med.

CONTACT

0041613287738; thilo.burkard@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 24, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): July 1, 2040
• Study Completion (Estimated): July 1, 2040
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CH (1)