The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study

NCT05747404 | Recruiting

• 1 other identifier: 09C040
• Study Type: observational
• Target: 1,500
• Locations: 2 countries
• Sites: 4

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

Conditions

Heart Valve Incompetence; Echocardiography, Transthoracic

Keywords

Functional tricuspid regurgitation; Three-dimensional echocardiography; Doppler echocardiography; Right ventricular function; Right atrial function

Outcome Measures

Primary Outcomes (1)

• Composite endpoint

  death from any cause and hospitalization for heart failure

  5 years

Other Outcomes (5)

• Right heart remodeling in various cardiac conditions affecting the right heart

  5 years

• 3D echo software validation

  1 year

• Improve grading of FTR

  2 years

Study Arms (2)

Functional tricuspid regurgitation

Patients with functional tricuspid regurgitation

Diagnostic Test: Echocardiography

Control subjects

Healthy volunteers

Interventions

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

Functional tricuspid regurgitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with at least mild functional tricuspid regurgitation and good apical acoustic window

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (4)

Istituto Auxologico Italiano, IRCCS

Milan, 20149, Italy

RECRUITING

University of Padova

Padua, 35128, Italy

TERMINATED

University of Medicine and Pharmacy Carol Davila

Bucharest, Romania

RECRUITING

University of Medicine and Pharmacy of Craiova

Craiova, 200349, Romania

RECRUITING

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Luigi Badano, MD, Ph.D.

  Istituto Auxologico Italiano, IRCCS

  STUDY DIRECTOR

Central Study Contacts

Luigi Badano, MD, Ph.D.

CONTACT

+3902619112319; l.badano@auxologico.it

Denisa Muraru, MD, Ph.D.

CONTACT

+3902619112319; d.muraru@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 28, 2023
• Study Start: April 21, 2020
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 21, 2027
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

IT (2); RO (2)