Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-01 @ 8:09 AM
Study NCT ID:
NCT05747404
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-04-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2023-02-17', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Right heart remodeling in various cardiac conditions affecting the right heart', 'timeFrame': '5 years', 'description': '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.)'}, {'measure': '3D echo software validation', 'timeFrame': '1 year', 'description': 'Assess the accuracy, and incremental diagnostic and prognostic value of a new software package to measure tricuspid annulus and valve geometry'}, {'measure': 'Improve grading of FTR', 'timeFrame': '2 years', 'description': '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'}, {'measure': 'Clinical significance of categorical grading', 'timeFrame': '5 years', 'description': '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'}, {'measure': 'Define different phenotypes of FTR', 'timeFrame': '5 years', 'description': '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'}], 'primaryOutcomes': [{'measure': 'Composite endpoint', 'timeFrame': '5 years', 'description': 'death from any cause and hospitalization for heart failure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional tricuspid regurgitation', 'Three-dimensional echocardiography', 'Doppler echocardiography', 'Right ventricular function', 'Right atrial function'], 'conditions': ['Heart Valve Incompetence', 'Echocardiography, Transthoracic']}, 'descriptionModule': {'briefSummary': "Prospective, multicenter, observational study to enroll consecutive patients with functional tricuspid regurgitation (FTR) with the primary aim to:\n\n* Use patients' outcomes as a reference to try to define the threshold values for the different grades of FTR severity; and secondary aims to:\n* 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.)\n* Assess the accuracy, and incremental diagnostic and prognostic value of a new software package to measure tricuspid annulus and valve geometry\n* 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\n* 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\n* 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with at least mild functional tricuspid regurgitation and good apical acoustic window', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years,\n* signed informed consent to be part of this study,\n* no pregnancy,\n* 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\n\nExclusion Criteria:\n\n* Unwillingness to be part of the study\n* Primary tricuspid valve disease\n* Patient already scheduled for tricuspid valve repair/replacement\n* Cardiac pacemaker, ICD or CRT leads\n* Poor acoustic window\n* Impossibility of left lateral decubitus position\n* Extreme heart rates (\\<50 or \\>100 bpm)\n* Previous LVAD implantation'}, 'identificationModule': {'nctId': 'NCT05747404', 'acronym': 'FUTURE 3D', 'briefTitle': 'The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study', 'orgStudyIdInfo': {'id': '09C040'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Functional tricuspid regurgitation', 'description': 'Patients with functional tricuspid regurgitation', 'interventionNames': ['Diagnostic Test: Echocardiography']}, {'label': 'Control subjects', 'description': 'Healthy volunteers'}], 'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': '\\- 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', 'armGroupLabels': ['Functional tricuspid regurgitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20149', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Badano, MD, Ph.D.', 'role': 'CONTACT', 'email': 'l.badano@auxologico.it', 'phone': '+3902619111', 'phoneExt': '2319'}, {'name': 'Denisa Muraru, MD, Ph.D.', 'role': 'CONTACT', 'email': 'd.muraru@auxologico.it', 'phone': '+3902619111', 'phoneExt': '2319'}, {'name': 'Michele Tomaselli, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mara Gavazzoni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francesco Perelli, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Cascella, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Samantha Fisicaro, RS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istituto Auxologico Italiano, IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '35128', 'city': 'Padua', 'status': 'TERMINATED', 'country': 'Italy', 'facility': 'University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Noela Radu, MD', 'role': 'CONTACT', 'email': 'noela.radu91@gmail.com'}], 'facility': 'University of Medicine and Pharmacy Carol Davila', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '200349', 'city': 'Craiova', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Diana Florescu, MD', 'role': 'CONTACT', 'email': 'dianarflorescu@yahoo.com'}], 'facility': 'University of Medicine and Pharmacy of Craiova', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}], 'centralContacts': [{'name': 'Luigi Badano, MD, Ph.D.', 'role': 'CONTACT', 'email': 'l.badano@auxologico.it', 'phone': '+3902619112319'}, {'name': 'Denisa Muraru, MD, Ph.D.', 'role': 'CONTACT', 'email': 'd.muraru@auxologico.it', 'phone': '+3902619112319'}], 'overallOfficials': [{'name': 'Luigi Badano, MD, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istituto Auxologico Italiano, IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be made available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}