Cardiovascular-Kidney-Metabolic SyndromeATRIO-CKMNCT07697469
Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization
An observational study of Cardiovascular-Kidney-Metabolic Syndrome and Atrial Cardiomyopathy, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan dysfunction and increased risk of atrial fibrillation, stroke, and heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular-Kidney-Metabolic Syndrome, Atrial Cardiomyopathy, Atrial Fibrillation
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- 10 Jul 2026to Apr 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults presenting for cardiovascular evaluation at the Internal Medicine I Department, Sf. Spiridon County Emergency Clinical Hospital Iasi, Romania, with cardiovascular-kidney-metabolic syndrome.
Who may be able to join
- Adults aged 18 years or older presenting for cardiovascular evaluation Signed written informed consent Agreement with all protocol requirements
Who cannot join
- Missing key data for ACM or CKM classification Hemodynamically significant valvular heart disease (greater than moderate severity) Mechanical or biological valve prostheses Temporary or permanent cardiac pacing Psychiatric pathology Thyroid pathology (active or untreated) Known cardiomyopathies (hypertrophic, dilated, restrictive, or infiltrative) Refusal to participate or inability to comply with protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Internal Medicine Clinic I "Prof. Datcu" - Sf. Spiridon County Emergency Clinical Hospital
Iași, Iaşi, 700111
About this study
Official title: Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization (ATRIO-CKM)
Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan dysfunction and increased risk of atrial fibrillation, stroke, and heart failure. Atrial cardiomyopathy (ACM) - defined as any structural, contractile, or electrical abnormality of the atria - is an increasingly recognized contributor to cardiovascular morbidity and mortality in this population. Despite growing interest in both conditions, their interplay remains poorly understood, limiting effective preventive strategies and risk-stratification approaches for this high-risk group.
CKM staging offers a practical framework for anticipating ACM onset and progression. Because adiposity-driven inflammation, insulin resistance, hypertension, and early kidney injury act as upstream drivers in CKM, the left atrium becomes an early indicator of hemodynamic load and fibrosis - often preceding sustained atrial fibrillation. Early non-invasive detection of ACM across CKM stages could shift care from treating complications to modifying the underlying substrate.
Read more
This prospective observational single-center cohort study aims to phenotype ACM non-invasively across all CKM stages at first diagnosis, using standard 12-lead ECG, advanced transthoracic echocardiography with speckle-tracking, a mechanistically selected biomarker panel (NT-proBNP, MR-proANP, Fetuin-A, FGF23), and cardiac MRI.
Adults aged 18 years or older presenting for cardiovascular evaluation are enrolled and grouped as CKM with ACM (study group) versus CKM without ACM (control group). All participants undergo a single standardized baseline evaluation including clinical examination, 12-lead ECG with Bayés interatrial block grading, comprehensive laboratory panel, and advanced echocardiography including left atrial global longitudinal strain by speckle-tracking.
Primary objective: characterize the relationship between ACM and CKM syndrome stages using non-invasive parameters at first diagnosis. Secondary objectives include assessment of clinical, biological, ECG, and imaging profiles of ACM in CKM; evaluation of left atrial function across CKM stages; examination of Bayés interatrial block correlations and the impact of SGLT2 inhibitors and GLP-1 receptor agonists on left atrial remodeling in HFpEF; and identification of independent ACM risk factors incorporating the full biomarker panel.
Statistical analyses include multivariable logistic regression, biomarker ROC analyses, and penalized regression for derivation of a pragmatic ACM risk score with internal validation. Expected outputs include prevalence estimates, effect sizes for ACM and CKM joint categories, biomarker performance metrics, and a clinic-ready checklist for risk-stratified prevention in outpatient settings.
- Conditions
- Cardiovascular-Kidney-Metabolic Syndrome, Atrial Cardiomyopathy, Atrial Fibrillation, Chronic Kidney Disease, Metabolic Syndrome
- Keywords
- atrial cardiomyopathy, CKM syndrome, on-invasive evaluation, atrial remodeling, Bayés interatrial block, speckle tracking, Fetuin-A, MR-proANP, FGF23, Atrial Fibrillation, Chronic Kidney Disease
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency, Chronic, Metabolic Syndrome, Atrial Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CKM with ACM | Patients with cardiovascular-kidney-metabolic syndrome and atrial cardiomyopathy, defined by presence of Bayés interatrial block on 12-lead ECG and/or reduced left atrial global longitudinal strain and/or elevated left atrial volume index on echocardiography | |
| CKM without ACM | Patients with cardiovascular-kidney-metabolic syndrome without atrial cardiomyopathy, serving as the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of atrial cardiomyopathy (ACM) across CKM syndrome stages
Prevalence of ACM defined by presence of Bayés interatrial block (grade 1 or 2) on 12-lead ECG and/or reduced left atrial global longitudinal strain and/or elevated left atrial volume index on transthoracic echocardiography, across CKM syndrome stages 0-4
Measured: Baseline (single evaluation visit)
Secondary outcomes (4)
Left atrial reservoir strain (LA-GLS %) across CKM syndrome stages assessed by speckle-tracking echocardiography
Measured: Baseline
Prevalence and grading of Bayés interatrial block and correlation with CKM-specific variables
Measured: Baseline
Distribution of biomarker levels (Fetuin-A, MR-proANP, FGF23, NT-proBNP) across ACM and CKM categories
Measured: Baseline
Independent risk factors for ACM in CKM syndrome identified by multivariable logistic regression incorporating clinical, ECG, echocardiographic and biomarker variables
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular-Kidney-Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIANA FLORIA, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Marius T Marcu, MD, PhD, Study director, Grigore T. Popa University of Medicine and Pharmacy IasiMugurel C Apetrii, MD, PhD, Study chair, Grigore T. Popa University of Medicine and Pharmacy IasiAnca E Stefan, MD, Study chair, Grigore T. Popa University of Medicine and Pharmacy IasiLaura Huiban, MD, PhD, Study chair, Grigore T. Popa University of Medicine and Pharmacy IasiAlexandru F Oancea, MD, Study chair, Grigore T. Popa University of Medicine and Pharmacy Iasi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697469
- Sponsor's protocol ID
- ATRIO-CKM
- Acronym
- ATRIO-CKM
- Status last verified
- Apr 2026
- First submitted
- 5 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data and analysis code will be shared where permitted by ethics approval and institutional policy. A synthetic dataset may be provided if full de-identification is not feasible.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization (ATRIO-CKM)
- ClinicalTrials.gov ID
- NCT07697469
- Acronym / sponsor ID
- ATRIO-CKM / ATRIO-CKM
- Conditions
- Cardiovascular-Kidney-Metabolic Syndrome, Atrial Cardiomyopathy, Atrial Fibrillation, Chronic Kidney Disease, Metabolic Syndrome
- Keywords
- atrial cardiomyopathy, CKM syndrome, on-invasive evaluation, atrial remodeling, Bayés interatrial block, speckle tracking, Fetuin-A, MR-proANP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Jul 2026 (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.
Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan dysfunction and increased risk of atrial fibrillation, stroke, and heart failure. Atrial cardiomyopathy (ACM) - defined as any structural, contractile, or electrical abnormality of the atria - is an increasingly recognized contributor to cardiovascular morbidity and mortality in this population. Despite growing interest in both conditions, their interplay remains poorly understood, limiting effective preventive strategies and risk-stratification approaches for this high-risk group.
CKM staging offers a practical framework for anticipating ACM onset and progression. Because adiposity-driven inflammation, insulin resistance, hypertension, and early kidney injury act as upstream drivers in CKM, the left atrium becomes an early indicator of hemodynamic load and fibrosis - often preceding sustained atrial fibrillation. Early non-invasive detection of ACM across CKM stages could shift care from treating complications to modifying the underlying substrate.
This prospective observational single-center cohort study aims to phenotype ACM non-invasively across all CKM stages at first diagnosis, using standard 12-lead ECG, advanced transthoracic echocardiography with speckle-tracking, a mechanistically selected biomarker panel (NT-proBNP, MR-proANP, Fetuin-A, FGF23), and cardiac MRI.
Adults aged 18 years or older presenting for cardiovascular evaluation are enrolled and grouped as CKM with ACM (study group) versus CKM without ACM (control group). All participants undergo a single standardized baseline evaluation including clinical examination, 12-lead ECG with Bayés interatrial block grading, comprehensive laboratory panel, and advanced echocardiography including left atrial global longitudinal strain by speckle-tracking.
Primary objective: characterize the relationship between ACM and CKM syndrome stages using non-invasive parameters at first diagnosis. Secondary objectives include assessment of clinical, biological, ECG, and imaging profiles of ACM in CKM; evaluation of left atrial function across CKM stages; examination of Bayés interatrial block correlations and the impact of SGLT2 inhibitors and GLP-1 receptor agonists on left atrial remodeling in HFpEF; and identification of independent ACM risk factors incorporating the full biomarker panel.
Statistical analyses include multivariable logistic regression, biomarker ROC analyses, and penalized regression for derivation of a pragmatic ACM risk score with internal validation. Expected outputs include prevalence estimates, effect sizes for ACM and CKM joint categories, biomarker performance metrics, and a clinic-ready checklist for risk-stratified prevention in outpatient settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKM with ACM | – | –Patients with cardiovascular-kidney-metabolic syndrome and atrial cardiomyopathy, defined by presence of Bayés interatrial block on 12-lead ECG and/or reduced left atrial global longitudinal strain and/or elevated left atrial volume index on echocardiography |
| CKM without ACM | – | –Patients with cardiovascular-kidney-metabolic syndrome without atrial cardiomyopathy, serving as the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting for cardiovascular evaluation at the Internal Medicine I Department, Sf. Spiridon County Emergency Clinical Hospital Iasi, Romania, with cardiovascular-kidney-metabolic syndrome.
Key inclusion criteria (1 listed)
- Adults aged 18 years or older presenting for cardiovascular evaluation Signed written informed consent Agreement with all protocol requirements
Key exclusion criteria (1 listed)
- Missing key data for ACM or CKM classification Hemodynamically significant valvular heart disease (greater than moderate severity) Mechanical or biological valve prostheses Temporary or permanent cardiac pacing Psychiatric pathology Thyroid pathology (active or untreated) Known cardiomyopathies (hypertrophic, dilated, restrictive, or infiltrative) Refusal to participate or inability to comply with protocol requirements
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
Prevalence of atrial cardiomyopathy (ACM) across CKM syndrome stages
Time frame: Baseline (single evaluation visit)
Prevalence of ACM defined by presence of Bayés interatrial block (grade 1 or 2) on 12-lead ECG and/or reduced left atrial global longitudinal strain and/or elevated left atrial volume index on transthoracic echocardiography, across CKM syndrome stages 0-4
4 secondary outcomes
Left atrial reservoir strain (LA-GLS %) across CKM syndrome stages assessed by speckle-tracking echocardiography
Time frame: Baseline
Prevalence and grading of Bayés interatrial block and correlation with CKM-specific variables
Time frame: Baseline
Distribution of biomarker levels (Fetuin-A, MR-proANP, FGF23, NT-proBNP) across ACM and CKM categories
Time frame: Baseline
Independent risk factors for ACM in CKM syndrome identified by multivariable logistic regression incorporating clinical, ECG, echocardiographic and biomarker variables
Time frame: Baseline
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 13 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data and analysis code will be shared where permitted by ethics approval and institutional policy. A synthetic dataset may be provided if full de-identification is not feasible.
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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.
Marius T Marcu, MD, PhD study director
Grigore T. Popa University of Medicine and Pharmacy Iasi
Mugurel C Apetrii, MD, PhD study chair
Grigore T. Popa University of Medicine and Pharmacy Iasi
Anca E Stefan, MD study chair
Grigore T. Popa University of Medicine and Pharmacy Iasi
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 Cardiovascular-Kidney-Metabolic Syndrome and Atrial Cardiomyopathy, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 1 inclusion and 1 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 13 Jul 2026. 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 Romania. 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 Mariana M Floria, MD, PhD (+40722364423, floria.mariana@umfiasi.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of atrial cardiomyopathy (ACM) across CKM syndrome stages (time frame: Baseline (single evaluation visit)). 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 13 Jul 2026.