Clinical trial NCT05749107: In-depth Characterization of Atriogenic Secondary Tricuspid Regurgitation Due to Atrial Fibrillation
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Valve Incompetence
Atrial Fibrillation, Persistent
Keywords: Functional tricuspid regurgitation
Three-dimensional echocardiography
Doppler echocardiography
Right ventricular function
Atrial fibrillation
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2023-03-01
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing echocardiography stud because of persistent/permanent atrial fibrillation

Brief 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 criteria: 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

Primary outcomes:
measure: Incidence of either moderate or severe functional tricuspid regurgitation
timeFrame: 1 year
measure: To identify the mechanisms leading to moderate/severe STR during AF.
timeFrame: 3 years
measure: To evaluate the extent of the right heart structure remodeling occurring after the recovery of the sinus rhythm and its effects on STR severity.
timeFrame: 3 years
Secondary outcomes:
measure: Development of an interpretable predictive model by using and integrating a variety of statistical and artificial intelligence (AI) techniques.
timeFrame: 3 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano, IRCCS
state: Select A State
city: MIlan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: