RecruitingNCT05749107

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

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


Sponsor

Istituto Auxologico Italiano

Enrollment

1,050 participants

Start Date

Dec 2, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at a specific type of leaky heart valve — tricuspid regurgitation caused by atrial fibrillation (an irregular heart rhythm) — to better understand how this condition develops and progresses over time. This is an observational study using echocardiograms (heart ultrasound). **You may be eligible if...** - You are over 18 years old - You have persistent or permanent atrial fibrillation (a long-term irregular heart rhythm) - Your heart's main pumping function is normal (ejection fraction >50%) - You have mild or no disease in other heart valves (mitral, aortic) - You are able to come in for follow-up appointments **You may NOT be eligible if...** - You are pregnant - You have a pacemaker or implanted cardiac defibrillator (ICD) - You have previously had heart valve surgery or a catheter-based valve procedure - You have had a heart transplant - Your tricuspid valve leakage is caused by a structural defect (organic disease) rather than atrial fibrillation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTEchocardiography

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

COMBINATION_PRODUCTProteomic analyses

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


Locations(2)

Istituto Auxologico Italiano, IRCCS

Milan, Select A State, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

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NCT05749107


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