Heart Valve IncompetenceFUTURE 3DNCT05747404
The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study
An observational study of Heart Valve Incompetence and Echocardiography, Transthoracic, run by Istituto Auxologico Italiano at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Incompetence, Echocardiography, Transthoracic
- What is being tested?
- Echocardiography
- How many people
- 1,500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 21 Apr 2020to 21 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with at least mild functional tricuspid regurgitation and good apical acoustic window
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Italy2 sites, 1 recruiting
- Recruiting
Istituto Auxologico Italiano, IRCCS
Milan, 20149
Luigi Badano, MD, Ph.D., +3902619111 ext. 2319, l.badano@auxologico.it
Denisa Muraru, MD, Ph.D., +3902619111 ext. 2319, d.muraru@auxologico.it
- Terminated
University of Padova
Padova, 35128
Romania2 sites, 2 recruiting
- Recruiting
University of Medicine and Pharmacy Carol Davila
Bucharest
Noela Radu, MD, noela.radu91@gmail.com
- Recruiting
University of Medicine and Pharmacy of Craiova
Craiova, 200349
Diana Florescu, MD, dianarflorescu@yahoo.com
About this study
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
- Being tested
- Echocardiography
- Keywords
- Functional tricuspid regurgitation, Three-dimensional echocardiography, Doppler echocardiography, Right ventricular function, Right atrial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Functional tricuspid regurgitation | Patients with functional tricuspid regurgitation Receives: Diagnostic Test: Echocardiography | |
| Control subjects | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
death from any cause and hospitalization for heart failure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start21 Apr 2020
- Primary completion1 Apr 2025 (estimated)
- Study completion21 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve IncompetenceStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Badano, MD, Ph.D., Study director, Istituto Auxologico Italiano, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747404
- Sponsor's protocol ID
- 09C040
- Acronym
- FUTURE 3D
- Status last verified
- Apr 2024
- First submitted
- 17 Feb 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study
- ClinicalTrials.gov ID
- NCT05747404
- Acronym / sponsor ID
- FUTURE 3D / 09C040
- Keywords
- Functional tricuspid regurgitation, Three-dimensional echocardiography, Doppler echocardiography, Right ventricular function, Right atrial function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 21 Apr 2027 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional tricuspid regurgitation | – | Diagnostic Test: EchocardiographyPatients with functional tricuspid regurgitation |
| Control subjects | – | –Healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with at least mild functional tricuspid regurgitation and good apical acoustic window
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Functional tricuspid regurgitation |
Primary outcome
Composite endpoint
Time frame: 5 years
death from any cause and hospitalization for heart failure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided. Data will be made available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luigi Badano, MD, Ph.D. study director
Istituto Auxologico Italiano, IRCCS
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Incompetence and Echocardiography, Transthoracic, run by Istituto Auxologico Italiano at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Badano, MD, Ph.D. (+3902619112319, l.badano@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.