Atrial Cardiomyopathy, Atrial Fibrillation, Cardiovascular-Kidney-Metabolic Syndrome, Chronic Kidney Disease, Metabolic Syndrome
Conditions
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
Brief 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. 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.
Interventions
None listed
Sponsors
Grigore T. Popa University of Medicine and Pharmacy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older presenting for cardiovascular evaluation Signed written informed consent Agreement with all protocol requirements
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of atrial cardiomyopathy (ACM) across CKM syndrome stages | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Left atrial reservoir strain (LA-GLS %) across CKM syndrome stages assessed by speckle-tracking echocardiography | Baseline |
| Prevalence and grading of Bayés interatrial block and correlation with CKM-specific variables | Baseline |
| Distribution of biomarker levels (Fetuin-A, MR-proANP, FGF23, NT-proBNP) across ACM and CKM categories | Baseline |
| Independent risk factors for ACM in CKM syndrome identified by multivariable logistic regression incorporating clinical, ECG, echocardiographic and biomarker variables | Baseline |
Countries
Romania
Contacts
CONTACTMariana M Floria, MD, PhD
CONTACTMaria Mihaela M Godun, MD
STUDY_DIRECTORMarius T Marcu, MD, PhD
Grigore T. Popa University of Medicine and Pharmacy Iasi
STUDY_CHAIRMugurel C Apetrii, MD, PhD
Grigore T. Popa University of Medicine and Pharmacy Iasi
STUDY_CHAIRAnca E Stefan, MD
Grigore T. Popa University of Medicine and Pharmacy Iasi
STUDY_CHAIRLaura Huiban, MD, PhD
Grigore T. Popa University of Medicine and Pharmacy Iasi
STUDY_CHAIRAlexandru F Oancea, MD
Grigore T. Popa University of Medicine and Pharmacy Iasi
Outcome results
None listed