Assessing functional tricuspid regurgitation using 3D echocardiography
Official title: The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study
Run by Istituto Auxologico Italiano · NCT05747404 · Data updated 2026-11-12
This study is testing a new 3D imaging method to better understand and measure the severity of tricuspid regurgitation in patients, helping doctors improve diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 4 sites (Milan and 3 other locations) |
| Status | Recruiting |
| Started | April 21, 2020 |
| Main results expected | April 1, 2025 |
| Study ends | April 21, 2027 |
| Registry record updated | April 16, 2024 |
| Trial ID | NCT05747404 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with specific cardiac conditions such as atrial fibrillation, pulmonary hypertension, or right ventricular cardiomyopathy.
✕Probably not a fit
Patients with primary tricuspid valve disease or those already scheduled for tricuspid valve repair may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to enroll patients with functional tricuspid regurgitation to establish reference outcomes and define threshold values for different grades of severity. It utilizes three-dimensional echocardiography to analyze the geometry of the right ventricle, right atrium, tricuspid annulus, and leaflets in relation to various cardiac conditions. The study also evaluates a new software package designed to measure tricuspid valve geometry and develop new parameters for assessing FTR severity. The goal is to enhance diagnostic and prognostic capabilities in patients with this condition.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic criteria and treatment strategies for patients with functional tricuspid regurgitation.
How similar studies have gone: While there have been studies on tricuspid regurgitation, this approach using 3D echocardiography and new software for geometry assessment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * older than 18 years, * signed informed consent to be part of this study, * no pregnancy, * the presence of at least one of the following cardiac conditions: a. Permanent atrial fibrillation b. Pulmonary arterial hypertension c. Left heart diseases with increased postcapillary pressure d. Right ventricular cardiomyopathy e. Right ventricular infarction f. Chronic thromboembolic pulmonary embolism g. Congenital diseases with right ventricular volume overload (atrial septal defect, interventricular septal defect, pulmonary regurgitation) h. Previous left heart valve surgery I. Good enough acoustic window and patient cooperation to obtain 3D echo data sets of the right ventricle, right atrium and tricuspid valve with a minimum temporal resolution of 20 vps l. Availability for clinical and echocardiography follow-up Exclusion Criteria: * Unwillingness to be part of the study * Primary tricuspid valve disease * Patient already scheduled for tricuspid valve repair/replacement * Cardiac pacemaker, ICD or CRT leads * Poor acoustic window * Impossibility of left lateral decubitus position * Extreme heart rates (\<50 or \>100 bpm) * Previous LVAD implantation
Where it's running
-
Istituto Auxologico Italiano, IRCCS
Milan, Italy Recruiting -
University of Medicine and Pharmacy Carol Davila
Bucharest, Romania Recruiting -
University of Medicine and Pharmacy of Craiova
Craiova, Romania Recruiting -
University of Padova
Padova, Italy Terminated
Study contacts
- Study coordinator: Luigi Badano, MD, Ph.D.
- Email: l.badano@auxologico.it
- Phone: +3902619112319
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.