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

NCT05749107 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1050

Last updated 2024-03-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV
  • Istituto Auxologico Italiano

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-02
Primary Completion
2024-12-02
Completion
2025-11-02

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05749107 on ClinicalTrials.gov