Actively Recruiting

Age: 18Years +
All Genders
NCT05747404

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study | DecenTrialz