NCT05749107

In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation

In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation. Prevalence, Mechanisms, Advanced Quantification of Regurgitation Severity, and Relative Impact of Sinus Rhythm Restoration on the 3D Remodeling of Right Heart Chambers and Tricuspid Valve Apparatus

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,050 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

1050 patients with persistent/permanent atrial fibrillation (AF) will be studied using conventional and advanced (three-dimensional and deformation imaging) echocardiography. Patients with moderate/severe isolated secondary tricuspid regurgitation (STR) will undergo blood tests to assess their proteomic profile and cardiac CT to measure the tricuspid annulus geometry. The project will aim to 1. assess the prevalence of moderate/severe isolated STR in patients with AF; 2. identify the mechanisms associated with the development of moderate-severe STR in patients with AF; 3. identify the proteomic profile associated with significant growth of tricuspid valve leaflets as a mechanism to protect patients with AF from the development of moderate/severe STR; 4. evaluate the effects of the restoration of sinus rhythm on the severity of STR and the remodeling of the right heart cardiac structures (i.e. right ventricle, right atrium, and tricuspid valve apparatus).

Conditions

• Heart Valve Incompetence
• Atrial Fibrillation, Persistent

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiography	Identify AF patients at risk of developing moderate/severe STR and those who will benefit from restoring the normal sinus rhythm
COMBINATION_PRODUCT	Proteomic analyses	To identify the mechanisms leading to moderate/severe STR during AF.

Timeline

• Start date: 2022-12-02
• Primary completion: 2024-12-02
• Completion: 2025-11-02
• First posted: 2023-03-01
• Last updated: 2024-03-15

Locations

2 sites across 1 country: Italy