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

Atrial Fibrillation, Persistent Clinical Trial

— ASTRA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749107
• Other study ID #: 09M202
• Status: Recruiting
• Start date: December 2, 2022
• Est. completion date: November 2, 2025

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Luigi Badano, MD, Ph.D.
• Phone: +390261911
• Email: l.badano[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: November 2, 2025
• Est. primary completion date: December 2, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Tricuspid Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	MIlan
Italy	Istituto Auxologico Italiano, IRCCS	Milan	Select A State

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of either moderate or severe functional tricuspid regurgitation	To assess the prevalence of moderate or severe atriogenic secondary tricuspid regurgitation (STR) in patients with persistent/permanent atrial fibrillation (AF), and to develop valve-specific metrics and parameters to assess STR severity by echocardiography.	1 year
Primary	To identify the mechanisms leading to moderate/severe STR during AF.	STR severity varies among patients with persistent/permanent AF and comparable RV and RA remodeling. The role of RV and RA size, shape, and function on the extent of tricuspid annulus dilation and dysfunction remains to be clarified.; Moreover, it is unknown whether the leaflets of the tricuspid valve can adapt to the stretch exerted on them by the progressive dilation of the tricuspid annulus. The contribution of leaflet adaptation to the pathophysiology of STR and its molecular determinants remains to be clarified	3 years
Primary	To evaluate the extent of the right heart structure remodeling occurring after the recovery of the sinus rhythm and its effects on STR severity.	Patients undergoing sustained cardioversion to sinus rhythm (both electrical and pharmacological) and/or ablation of AF, will be followed at 1, 3, and 12 months after the procedure by recording electrocardiogram and complete 2D Doppler and 3DE to assess the extent of the remodeling of the RV, the RA, and the tricuspid valve apparatus. Patients with atriogenic moderate/severe STR without clinical indication to either cardioversion or ablation of the AF, and patients with none/mild atriogenic STR will be followed with clinical assessment, and complete 2D, Doppler and 3DE at 6 months and 1 year.; The severity of STR will be quantified by measuring EROA, regurgitant volume, and regurgitant fraction.	3 years
Secondary	Development of an interpretable predictive model by using and integrating a variety of statistical and artificial intelligence (AI) techniques.	Clinical, echocardiographic, and biomarker parameters that might predict either the development of moderate/severe STR in patients with AF or the likelihood of reduction of STR severity after cardioversion in sinus rhythm will be identified and integrated in an expert system based on fuzzy reasoning.	3 years