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

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Atrial Fibrillation, Persistent; Heart Valve Incompetence

Treatments: Diagnostic Test: Echocardiography; Combination Product: Proteomic analyses

Study type: Observational

Funder types: Other

Identifiers

NCT05749107

09M202

Details and patient eligibility

About

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).

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

1,050 participants in 1 patient group

Atrial secondary tricuspid regurgitation

Description:

Patients with persistent/permanent atrial fibrillation and any degree of isolated tricuspid regurgitation

Treatment:

Diagnostic Test: Echocardiography

Combination Product: Proteomic analyses