Characterizing tricuspid regurgitation in patients with 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
This study looks at how common tricuspid regurgitation is in people with atrial fibrillation and whether fixing their heart rhythm can change their heart's structure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1050 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 2 sites (Milan, Select A State and 1 other locations) |
| Trial ID | NCT05749107 on ClinicalTrials.gov |
What this trial studies
This observational study will analyze 1050 patients with persistent or permanent atrial fibrillation using both conventional and advanced echocardiography techniques. The focus will be on patients with moderate to severe isolated secondary tricuspid regurgitation, who will undergo blood tests for proteomic profiling and cardiac CT scans to assess tricuspid annulus geometry. The study aims to determine the prevalence of tricuspid regurgitation in this population, explore the mechanisms behind its development, and evaluate the impact of restoring sinus rhythm on heart structure remodeling.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with persistent or permanent atrial fibrillation and specific echocardiographic criteria.
Not a fit: Patients with organic tricuspid regurgitation or those who have had previous heart valve surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of tricuspid regurgitation in patients with atrial fibrillation.
How similar studies have performed: While this study employs advanced imaging techniques, similar studies have shown promise in understanding heart valve incompetence, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan, Select A State and 1 other locations
- Istituto Auxologico Italiano, IRCCS — Milan, Select A State, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — MIlan, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Luigi Badano, MD, Ph.D.
- Email: l.badano@auxologico.it
- Phone: +390261911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.