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

NCT ID: NCT05724225

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2023-12-29

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.

Conditions

Tricuspid Valve Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

First group with atrial fibrillation disease

10 Atrial fibrillation(AF), predominant right atrial dilatation with at least moderate IT

No interventions assigned to this group

Second group with atrial fibrillation disease and tricuspid insufficiency

10 AF, predominantly right atrial dilatation without TI (or TI no more than mild)

No interventions assigned to this group

Third group with AF and mitral insufficiency

10 AF, predominantly left atrial dilatation with at least moderate MI

No interventions assigned to this group

Fourth group with atrial fibrillation and IM

10 AF, predominantly left atrial dilatation without MI (or no more than mild MI)

No interventions assigned to this group

Fifth group with tricuspid insufficiency

10 IT at least moderate to right ventricular remodeling in patients with pulmonary hypertension

No interventions assigned to this group

Sixth group with mitral insufficiency

10 MI at least average from left ventricular remodeling from left ventricular dysfunction

No interventions assigned to this group

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Pedicino Daniela

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istituto Auxologico Italiano IRCSS Ospedale San Luca

Milan, , Italy

Countries

Italy

Other Identifiers

4424

Identifier Type: -

Identifier Source: org_study_id