Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT07042360
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart failure hospitalisation rate', 'timeFrame': '1 year', 'description': 'Heart failure hospitalization rate of subjects at 1 year'}, {'measure': 'Tricuspid valve intervention rate', 'timeFrame': '1 year', 'description': 'Tricuspid valve intervention rate of subjects at 1 year'}, {'measure': 'Cardiovascular mortality rate', 'timeFrame': '1 year', 'description': 'Cardiovascular mortality rate of subjects at 1 year'}], 'secondaryOutcomes': [{'measure': 'Heart failure hospitalisation rate', 'timeFrame': '6-month', 'description': 'Heart failure hospitalization rate of subjects at 6-month'}, {'measure': 'Tricuspid valve intervention rate', 'timeFrame': '12-month', 'description': '1-year tricuspid valve intervention of subjects at 12-month'}, {'measure': 'NYHA Classification', 'timeFrame': '6-month', 'description': 'Assess 6-month symptom burden via NYHA classification'}, {'measure': 'NYHA Classification', 'timeFrame': '12-month', 'description': 'Assess 1 year symptom burden via NYHA classification'}, {'measure': 'Quality of Life measures', 'timeFrame': '6-month', 'description': 'Assess Quality of Life measures of subject at 6-month via Kansas City Cardiomyophthy Questionnaire-12.\n\nScore range from 0-100, higher score indicates better outcome (Better Quality of Life/ less affected by Symptoms)'}, {'measure': 'Quality of Life measures', 'timeFrame': '12-month', 'description': 'Assess Quality of Life measures of subject at 12-month via Kansas City Cardiomyophthy Questionnaire-12 Score range from 0-100, higher score indicates better outcome (Better Quality of Life/ less affected by Symptoms)'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '6-month', 'description': 'To monitor the short term use of intravenous diuretics at day-center at 6-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '6-month', 'description': 'To monitor the increase of total daily dose oral diuretics at day-center at 6-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '6-month', 'description': 'To monitor the short term use of inotrope at day-center at 6-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '6-month', 'description': 'To monitor the application of aquapheresis at day-center at 6-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '12-month', 'description': 'To monitor the short term use of intravenous diuretics at day-center at 12-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '12-month', 'description': 'To monitor the increase of total daily dose oral diuretics at day-center at 12-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '12-month', 'description': 'To monitor the short term use of inotrope at day-center at 12-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '12-month', 'description': 'To monitor the application of aquapheresis at day-center at 12-month follow-up to reflect if there is any intensification of medical therapy for treatment of Tricuspid Regurgitation'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in TAPSE in patients at 12-months vs baseline using 3D Echocardiogram meaurements at 12-month follow up'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in 3D Right Ventricle Ejection Fraction (RVEF) using 3D Echocardiogram meaurements in patients at 12-months vs baseline'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in TAPSE/RVOT ratio in patients at 12-months vs baseline'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in 3D RV volume in patients at 12-months vs baseline'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in Right Ventricle size in patients at 12-months vs baseline using 3D Echocardiogram meaurements'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in Right Ventricle Systolic Pressure (RVSP) in patients at 12-months vs baseline using 3D Echocardiogram meaurements at 12-month follow up'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in Left ventricular ejection fraction (LVEF) in patients at 12-months vs baseline'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in Left ventricular global longitudinal strain (LV GLS) in patients at 12-months vs baseline 8. 1 year worsening of left ventricular function (LVEF, GLS, LVOT VTI)'}, {'measure': 'Intensification of medical therapy', 'timeFrame': '6-month', 'description': '6-month intensification of medical therapy of subjects (including short term use of intravenous diuretics at day-center, increase oral diuretics dose or frequency, short term use of inotrope at day-center, application of aquapheresis'}, {'measure': 'Echocardiographic parameters changes', 'timeFrame': '12-month', 'description': 'Compare changes in Left ventricular outflow tract (LVOT VTI) in patients at 12-months vs baseline using 3D Echocardiogram meaurements at 12-month follow up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tricuspid Regurgitation']}, 'descriptionModule': {'briefSummary': 'Tricuspid regurgitation (TR) is an increasingly recognized valvular heart disease associated with high morbidity and mortality. With the availability of various novel transcatheter tricuspid interventions, it is no longer considered a "forgotten valve." Heart failure with preserved ejection fraction (HFpEF) is a prevalent condition also characterized by high morbidity and mortality. The prevalence of moderate to severe TR in the general population is 3% to 6%; however, in patients with heart failure (with reduced or preserved ejection fraction \\[EF\\]), the prevalence is 10% to 29%, rising to up to 39% in patients with HFpEF and atrial fibrillation (AF). The EuroTR registry, an international registry including patients who underwent percutaneous treatment for severe TR, reported that 72% of patients had a left ventricular ejection fraction (LVEF) ≥50%. In a subgroup of patients with right heart catheterization data, 68% had a pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg, indicating that many of these patients may have HFpEF. Patients with significant TR have also been shown to experience irreversible liver derangement and cirrhosis. Non-invasive evaluation of liver stiffness (LS), measured by transient elastography, has recently received increased attention in patients with heart failure and has been shown to closely correlate with right-sided filling pressures. LS has been used to predict adverse outcomes in patients undergoing transcatheter aortic valve (TA) surgery with concomitant left-sided valve surgery.\n\nOn the other hand, the Remote Dielectric Sensing System (ReDS; Sensible Medical Innovations, Israel) is a device that measures lung fluid non-invasively and provides an objective and reproducible index of volume status. It is an FDAapproved device for heart failure patients. ReDS measurements are presented as the percentage of fluid relative to lung volume, with normal values ranging between 20% to 35%. Studies have demonstrated excellent correlations between the ReDS index and computed tomography (CT)-measured lung water and invasively determined hemodynamics. Additionally, it has been shown to predict heart failure rehospitalization in patients with acute heart failure.\n\nGiven the emergence of novel transcatheter tricuspid interventions and the established link between TR, HFpEF, and markers such as liver stiffness and lung fluid index (measured by ReDS), this study will examine the intricate interplay between these conditions and their shared pathophysiology. By analyzing left and right heart function, risk factors, and treatment outcomes, the research aims to phenotype TR using non-invasive assessment tools to predict clinical outcomes and improve treatment strategies for patients with different types of TR. Our findings will contribute to developing more effective and personalized treatment plans for patients with TR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'By analyzing left and right heart function, risk factors, and treatment outcomes, the research aims to phenotype TR using non-invasive assessment tools to predict clinical outcomes and improve treatment strategies for patients with different types of TR.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with \\>=moderate TR\n* able to consent for the study.\n\nExclusion Criteria:\n\n1. LVEF \\<=40%\n2. Have significant left sided organic valvular heart disease (i.e. \\>=moderate AS, \\>=moderate MS, \\>=moderate MR of organic or mixed aetiology), dysfunctional mitral valve replacement or aortic valve replacement\n3. Prior tricuspid valve interventions (eg TriClip, tricuspid valve repair or replacement) (To allow accurate transient elastography)\n4. Known hepatocellular carcinoma\n5. Known portal vein thrombosis\n6. Established liver cirrhosis with a known liver-related aetiology\n7. Hepatitis C infection and not on treatment\n8. Uncontrolled hepatitis (e.g. hepatitis B infection, autoimmune hepatitis)\n9. Fatty liver with evidence of non-alcoholic fatty liver disease or cirrhosis (to allow accurate non-invasive lung fluid assessment)\n10. recent rib fracture (\\<3 months) with or without flail chest\n11. BMI \\<20 or \\>36\n12. Height \\<155cm or \\>195cm\n13. Patients with right lung tumor\n14. Patients with right sided pacemaker\n15. Patients with known underlying exudative right pleural effusion'}, 'identificationModule': {'nctId': 'NCT07042360', 'acronym': 'TRIREF', 'briefTitle': 'Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Wales Hospital, Shatin, Hong Kong'}, 'officialTitle': 'Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation', 'orgStudyIdInfo': {'id': '2025.229'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical treatment', 'description': 'Patient with \\>= moderate TR for medical treatment', 'interventionNames': ['Diagnostic Test: ReDs Pro', 'Diagnostic Test: Fibroscan']}, {'label': 'Intervention', 'description': 'PAtient with \\>= moderate TR for transcather intervention', 'interventionNames': ['Diagnostic Test: ReDs Pro', 'Diagnostic Test: Fibroscan']}], 'interventions': [{'name': 'ReDs Pro', 'type': 'DIAGNOSTIC_TEST', 'description': 'The basic principle invovles emitting low-power electromagnetic sgnals into the lungs and measuring the dielectric properties of lung tissue\n\nThe varing dielectric constants of these components result in differences in the impedance values for electromagnetic waves. Therefore, using the impedance method allows the estimation of the dielectric properties of lung tissue, which can be further converted into lung fluid content data through calculations.', 'armGroupLabels': ['Intervention', 'Medical treatment']}, {'name': 'Fibroscan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Using external ultrasound scanner to check fo rliver stiffness using acoustic energy', 'armGroupLabels': ['Intervention', 'Medical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Chak Yu So', 'role': 'CONTACT', 'email': 'kentso987@gmail.com', 'phone': '85260338536'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Wales Hospital, Shatin, Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clnincal assistant professor', 'investigatorFullName': 'Dr So Chak Yu kent', 'investigatorAffiliation': 'Prince of Wales Hospital, Shatin, Hong Kong'}}}}