Cradiovascular-kidney-liver-metabolic (CKLM) SyndromeNCT07084688
Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry
An observational study of Cradiovascular-kidney-liver-metabolic (CKLM) Syndrome and Cardiovascular-kidney-metabolic Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cradiovascular-kidney-liver-metabolic (CKLM) Syndrome, Cardiovascular-kidney-metabolic Syndrome
- How many people
- 1,500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Jul 2025to Jul 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 200-300 participants with cardiovascular-kidney-metabolic (CKM) syndrome per year at the Medical Outpatient Department of the University Hospital Basel
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- History of symptomatic HF
- History of HF hospitalisation
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Medical Outpatient Department of the University Hospital Basel
Basel, Canton of Basel-City, 4031
Annina Vischer, PD Dr. med., 0041613286630, annina.vischer@usb.ch
Annina Vischer, PD Dr. med.
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Syndrome, Cardiovascular Diseases, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline, 6, 12 months and annually up to 10 years
Frequency of microalbuminuria
Frequency of microalbuminuria
Measured: At baseline, 6, 12 months and annually up to 5 years
Frequency of increased HbA1c
Frequency of increased HbA1c
Measured: At baseline, 6, 12 months and annually up to 5 years
Assessment of Fib4-score
Assessment of Fib-4 score
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: At baseline and annually up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start14 Jul 2025 (estimated)
- Primary completionJul 2040 (estimated)
- Study completionJul 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cradiovascular-kidney-liver-metabolic (CKLM) SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annina Vischer, PD Dr. med., Principal investigator, Medical Outpatient Department and Hypertension Clinic, ESH Hypertension Centre of Excellence, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084688
- Sponsor's protocol ID
- 2025-00756; am25Vischer
- Other IDs
- 2025
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Cardiovascular-Kidney-Liver-Metabolic (CKLM) Registry
- ClinicalTrials.gov ID
- NCT07084688
- Acronym / sponsor ID
- 2025-00756; am25Vischer
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 14 Jul 2025 (estimated)
- Primary completion
- Jul 2040 (estimated)
- Study completion
- Jul 2040 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 200-300 participants with cardiovascular-kidney-metabolic (CKM) syndrome per year at the Medical Outpatient Department of the University Hospital Basel
Key inclusion criteria (8 listed)
- 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:
- Willingness to provide informed consent
Key exclusion criteria (9 listed)
- Individuals with CKM syndrome stage 4 according to the AHA
- Inability to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
Frequency of microalbuminuria
Time frame: At baseline, 6, 12 months and annually up to 5 years
Frequency of microalbuminuria
Frequency of increased HbA1c
Time frame: At baseline, 6, 12 months and annually up to 5 years
Frequency of increased HbA1c
Assessment of Fib4-score
Time frame: At baseline, 6, 12 months and annually up to 5 years
Assessment of Fib-4 score
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)
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annina Vischer, PD Dr. med. principal investigator
Medical Outpatient Department and Hypertension Clinic, ESH Hypertension Centre of Excellence, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cradiovascular-kidney-liver-metabolic (CKLM) Syndrome and Cardiovascular-kidney-metabolic Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annina Vischer, PD Dr. med. (0041613286630, annina.vischer@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of cardiovascular diseases (time frame: At baseline, 6, 12 months and annually up to 10 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.