Actively Recruiting
The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study
Led by Istituto Auxologico Italiano · Updated on 2024-04-16
1500
Participants Needed
4
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicenter, observational study to enroll consecutive patients with functional tricuspid regurgitation (FTR) with the primary aim to: * Use patients' outcomes as a reference to try to define the threshold values for the different grades of FTR severity; and secondary aims to: * Use 3D echocardiography to assess the relationships among the geometry (size and shape) of the right ventricle, right atrium, tricuspid annulus, and tricuspid leaflets according to the underlying cardiac condition (i.e., atrial fibrillation, pulmonary hypertension, right ventricular cardiomyopathy, congenital heart diseases, etc.) * Assess the accuracy, and incremental diagnostic and prognostic value of a new software package to measure tricuspid annulus and valve geometry * Develop new parameters of FTR severity that take into account the lower momentum of the tricuspid regurgitant jet (compared with the mitral regurgitation jet), the complex anatomy of the regurgitant orifice, and both the intra-beat and respiratory variation of the regurgitant volume * Test the hypothesis that there is no actual grading but a continuum of increased risk of adverse outcome with the increase of FTR severity, and we need robust quantitative metrics (for example, the regurgitant fraction - currently not included in guidelines - which takes into account the right ventricular volume and function) more than grading schemes to assess the severity of the diseases and the effect of treatments * Test the hypothesis that the relationship between FTR severity and the outcome may be different according to the underlying cardiac condition (i.e., atrial fibrillation, pulmonary hypertension, right ventricular cardiomyopathy, congenital heart diseases, post-cardiac surgery, etc.) as this will affect the timing for interventions
CONDITIONS
Official Title
The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent to participate in the study
- Not pregnant
- Presence of at least one of the following: permanent atrial fibrillation, pulmonary arterial hypertension, left heart diseases with increased postcapillary pressure, right ventricular cardiomyopathy, right ventricular infarction, chronic thromboembolic pulmonary embolism, congenital diseases with right ventricular volume overload (such as atrial septal defect, interventricular septal defect, pulmonary regurgitation), or previous left heart valve surgery
- Good acoustic window and patient cooperation to obtain 3D echocardiography data of the right ventricle, right atrium, and tricuspid valve with at least 20 volumes per second
- Availability for clinical and echocardiography follow-up
You will not qualify if you...
- Unwillingness to participate in the study
- Primary tricuspid valve disease
- Already scheduled for tricuspid valve repair or replacement
- Presence of cardiac pacemaker, ICD, or CRT leads
- Poor acoustic window
- Unable to lie in left lateral decubitus position
- Extreme heart rates below 50 bpm or above 100 bpm
- Previous left ventricular assist device (LVAD) implantation
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Istituto Auxologico Italiano, IRCCS
Milan, Italy, 20149
Actively Recruiting
2
University of Padova
Padova, Italy, 35128
Terminated
3
University of Medicine and Pharmacy Carol Davila
Bucharest, Romania
Actively Recruiting
4
University of Medicine and Pharmacy of Craiova
Craiova, Romania, 200349
Actively Recruiting
Research Team
L
Luigi Badano, MD, Ph.D.
CONTACT
D
Denisa Muraru, MD, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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