RecruitingNCT05749107

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


Sponsor

Istituto Auxologico Italiano

Enrollment

1,050 participants

Start Date

Dec 2, 2022

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • age\> 18 years
  • persistent/permanent atrial fibrillation
  • good acoustic apical window
  • left ventricular ejection fraction \> 50%
  • pulmonary artery systolic pressure\< 50 mm Hg
  • no more than mild mitral or aortic valve disease
  • ability to attend clinical and echocardiographic follow-ups
  • signature of the study informed consent

Exclusion Criteria5

  • pregnancy
  • implanted pace-maker or ICD
  • previous heart valve surgery or transcatheter treatment
  • previous heart transplant
  • organic tricuspid regurgitation

Interventions

DIAGNOSTIC_TESTEchocardiography

Identify AF patients at risk of developing moderate/severe STR and those who will benefit from restoring the normal sinus rhythm

COMBINATION_PRODUCTProteomic analyses

To identify the mechanisms leading to moderate/severe STR during AF.


Locations(2)

Istituto Auxologico Italiano, IRCCS

Milan, Select A State, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

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NCT05749107


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