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

Tricuspid Valve Insufficiency Clinical Trial

— ATOMIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05724225
• Other study ID #: 4424
• Status: Active, not recruiting
• Start date: October 6, 2021
• Est. completion date: December 29, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 29, 2023
• Est. primary completion date: November 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCSS Ospedale San Luca	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein expression	Evaluation of the protein expression of the altered biomarkers in the 6 study groups	1 years
Secondary	Correlation between circulating protein biomarkers and diagnostic parameters	Analysis of the correlation between circulating protein biomarkers and echocardiographic parameters of mitral and tricuspid valve leaflet remodeling	6 months
Secondary	Correlation between clinical data and diagnostic imaging markers	Evaluation of the correlation between clinical data (gender, age, AF duration) and echocardiographic imaging markers	6 months