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Prospective, multicenter, observational study to enroll consecutive patients with functional tricuspid regurgitation (FTR) with the primary aim to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional tricuspid regurgitation | Patients with functional tricuspid regurgitation |
| |
| Control subjects | Healthy volunteers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | - 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint | death from any cause and hospitalization for heart failure | 5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Right heart remodeling in various cardiac conditions affecting the right heart | 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.) |
Inclusion Criteria:
Exclusion Criteria:
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Patients with at least mild functional tricuspid regurgitation and good apical acoustic window
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Badano, MD, Ph.D. | Contact | +3902619112319 | l.badano@auxologico.it | |
| Denisa Muraru, MD, Ph.D. | Contact | +3902619112319 | d.muraru@auxologico.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Badano, MD, Ph.D. | Istituto Auxologico Italiano, IRCCS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Auxologico Italiano, IRCCS | Recruiting | Milan | 20149 | Italy |
Data will be made available upon reasonable request
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 5 years |
| 3D echo software validation | Assess the accuracy, and incremental diagnostic and prognostic value of a new software package to measure tricuspid annulus and valve geometry | 1 year |
| Improve grading of FTR | 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 bot the intra-beat and respiratory variation of the regurgitant volume | 2 years |
| Clinical significance of categorical grading | 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 | 5 years |
| Define different phenotypes of FTR | Test the hypothesis that the relationship between FTR severity and 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 | 5 years |
| University of Padova | Terminated | Padova | 35128 | Italy |
| University of Medicine and Pharmacy Carol Davila | Recruiting | Bucharest | Romania |
|
| University of Medicine and Pharmacy of Craiova | Recruiting | Craiova | 200349 | Romania |
|
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |