FUTURE 3D: The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT05747404

Collaborator

(none)

1,500

Enrollment

Locations

Anticipated Duration (Months)

375

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Incompetence Echocardiography, Transthoracic	Diagnostic Test: Echocardiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study

Actual Study Start Date :

Apr 21, 2020

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
Functional tricuspid regurgitation Patients with functional tricuspid regurgitation	Diagnostic Test: Echocardiography - 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
Control subjects Healthy volunteers

Arm

Intervention/Treatment

Functional tricuspid regurgitation

Patients with functional tricuspid regurgitation

Diagnostic Test: Echocardiography

- 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

Control subjects

Healthy volunteers

Outcome Measures

Primary Outcome Measures

Composite endpoint [5 years]
death from any cause and hospitalization for heart failure

Other Outcome Measures

Right heart remodeling in various cardiac conditions affecting the right heart [5 years]
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.)
3D echo software validation [1 year]
Assess the accuracy, and incremental diagnostic and prognostic value of a new software package to measure tricuspid annulus and valve geometry
Improve grading of FTR [2 years]
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
Clinical significance of categorical grading [5 years]
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
Define different phenotypes of FTR [5 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Istituto Auxologico Italiano, IRCCS	Milan	Italy	20149
2	University of Padova	Padova	Italy	35128
3	University of Medicine and Pharmacy Carol Davila	Bucharest	Romania
4	University of Medicine and Pharmacy of Craiova	Craiova	Romania	200349