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: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Combination product
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Istituto Auxologico Italiano, IRCCS
RECRUITING
Milan
Contact Information
Primary
Luigi Badano, MD, Ph.D.
l.badano@auxologico.it
+390261911
Backup
Denisa Muraru, MD, Ph.D.
luigi.badano@unimib.it
+390261911
Time Frame
Start Date: 2022-12-02
Estimated Completion Date: 2025-11-02
Participants
Target number of participants: 1050
Treatments
Atrial secondary tricuspid regurgitation
Patients with persistent/permanent atrial fibrillation and any degree of isolated tricuspid regurgitation
Sponsors
Leads: Istituto Auxologico Italiano
Collaborators: Ministry of Health, Italy

This content was sourced from clinicaltrials.gov