- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07697469
Atrial Cardiomyopathy in Patients With Cardiovascular-Kidney-Metabolic Syndrome: Non-invasive Characterization (ATRIO-CKM)
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.
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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Mariana M Floria, MD, PhD
- Telefonnummer: +40722364423
- E-post: floria.mariana@umfiasi.ro
Studer Kontakt Backup
- Navn: Maria Mihaela M Godun, MD
- Telefonnummer: +40755777809
- E-post: maria_godun@yahoo.com
Studiesteder
-
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Iaşi
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Iași, Iaşi, Romania, 700111
- Internal Medicine Clinic I "Prof. Datcu" - Sf. Spiridon County Emergency Clinical Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of atrial cardiomyopathy (ACM) across CKM syndrome stages
Tidsramme: Baseline (single evaluation visit)
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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
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Baseline (single evaluation visit)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Left atrial reservoir strain (LA-GLS %) across CKM syndrome stages assessed by speckle-tracking echocardiography
Tidsramme: Baseline
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Baseline
|
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Prevalence and grading of Bayés interatrial block and correlation with CKM-specific variables
Tidsramme: Baseline
|
Baseline
|
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Distribution of biomarker levels (Fetuin-A, MR-proANP, FGF23, NT-proBNP) across ACM and CKM categories
Tidsramme: Baseline
|
Baseline
|
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Independent risk factors for ACM in CKM syndrome identified by multivariable logistic regression incorporating clinical, ECG, echocardiographic and biomarker variables
Tidsramme: Baseline
|
Baseline
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Marius T Marcu, MD, PhD, Grigore T. Popa University of Medicine and Pharmacy Iasi
- Studiestol: Mugurel C Apetrii, MD, PhD, Grigore T. Popa University of Medicine and Pharmacy Iasi
- Studiestol: Anca E Stefan, MD, Grigore T. Popa University of Medicine and Pharmacy Iasi
- Studiestol: Laura Huiban, MD, PhD, Grigore T. Popa University of Medicine and Pharmacy Iasi
- Studiestol: Alexandru F Oancea, MD, Grigore T. Popa University of Medicine and Pharmacy Iasi
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Patologiske tilstander, anatomiske
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Hjertesykdommer
- Kronisk sykdom
- Sykdomsattributter
- Metabolske sykdommer
- Arytmier, hjerte
- Glukosemetabolismeforstyrrelser
- Nyreinsuffisiens
- Insulinresistens
- Hyperinsulinisme
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Metabolsk syndrom
- Atrieflimmer
- Nyresvikt, kronisk
- Atrial remodellering
Andre studie-ID-numre
- ATRIO-CKM
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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