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Atriogenic Tricuspid Selected, Omics Profile, Multimodality Imaging and Clinical Outcomes

Atriogenic Tricuspid Regurgitation, Selected Omics Profile, Multimodality Imaging and Clinical Outcomes (the ATOMIC Study)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05724225
Acronym
ATOMIC
Enrollment
60
Registered
2023-02-13
Start date
2021-10-06
Completion date
2023-12-29
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Valve Insufficiency

Keywords

functional tricuspid valve regurgitation, atrial fibrillation

Brief summary

The aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with ITF and isolated AF, in comparison with patients with ITF from right ventricular remodeling, patients with atriogenic MI and left ventricular remodeling. To achieve these aims, markers obtained from cardiovascular imaging methods, such as 3D echocardiogram, and biomarkers isolated from the peripheral blood of the study participants will be considered.

Detailed description

Advances in echocardiography and, in particular, the development of three-dimensional echocardiography have allowed a more accurate analysis of the morphology of the tricuspid valve and a detailed understanding of the mechanisms underlying its insufficiency. From a clinical point of view, ITF is divided into a primary form, less frequent (8-10%), caused by primary alterations of the tricuspid valve apparatus, acquired or congenital, and in a functional form, the most frequent, conventionally associated in most cases with coexisting pathologies of the left heart or primitive pathologies of the right heart. More recently, long-lasting persistent atrial fibrillation (AF) has been associated with the development of ITF in the presence of structurally normal valve leaflets, preserved right ventricular size and function, and right atrial dilatation. This form of ITF, defined as atrial functional, could benefit from a different therapeutic management compared to the classic form, more commonly caused by right ventricular dilatation and dysfunction (ventricular functional IT). However, not all patients with AF and tricuspid annulus dilatation develop valvular insufficiency and, on the other hand, with the same valvular annulus dilatation and right atrial size, the prevalence of severe IT forms is extremely variable. This could depend on different adaptive mechanisms implemented by the valve leaflet tissue that lead to their growth or not in response to atrial remodeling and valve annulus dilatation, representing a key factor in the development and progression of the disease. Atriogenic ITF. If confirmed, these observations could lead to a better prognostic classification and different therapeutic perspectives for patients with AF at risk of developing forms of severe ITF and congestive heart failure.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

\- Admitted to the Department of cardiological, neurological and metabolic sciences of the San Luca hospital with a diagnosis of persistent atrial fibrillation

Exclusion criteria

* Patient aged \<18 years; * Pregnancy; * Chronic inflammatory diseases; * Autoimmune diseases; * Tumor diseases; * Chronic renal failure with eGFR \< 30 mL/min;

Design outcomes

Primary

MeasureTime frameDescription
Protein expression1 yearsEvaluation of the protein expression of the altered biomarkers in the 6 study groups

Secondary

MeasureTime frameDescription
Correlation between circulating protein biomarkers and diagnostic parameters6 monthsAnalysis of the correlation between circulating protein biomarkers and echocardiographic parameters of mitral and tricuspid valve leaflet remodeling
Correlation between clinical data and diagnostic imaging markers6 monthsEvaluation of the correlation between clinical data (gender, age, AF duration) and echocardiographic imaging markers

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026