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

NCT ID: NCT05749107

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1050 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-02

Study Completion Date

2025-11-02

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Valve Incompetence Atrial Fibrillation, Persistent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Atrial secondary tricuspid regurgitation

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

Echocardiography

Intervention Type DIAGNOSTIC_TEST

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

Proteomic analyses

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Echocardiography

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

Intervention Type DIAGNOSTIC_TEST

Proteomic analyses

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Italy

OTHER_GOV

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Auxologico Italiano, IRCCS

Milan, Select A State, Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Luigi Badano, MD, Ph.D.

Role: CONTACT

+390261911 ext. 2319

Denisa Muraru, MD, Ph.D.

Role: CONTACT

+390261911 ext. 2319

Facility Contacts

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Luigi Badano, MD, Ph.D.

Role: primary

+3902619111 ext. 2319

Denisa Muraru, MD, Ph.D.

Role: backup

+3902619111 ext. 2319

Pasquale Vergara, MD, Ph.D.

Role: primary

Other Identifiers

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09M202

Identifier Type: -

Identifier Source: org_study_id

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