Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
Study NCT ID:
NCT06663566
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-29
First Post:
2024-10-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload
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': 90}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-27', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right heart dysfunction', 'timeFrame': '15 days', 'description': 'Central venous pressure（cmH2O）'}, {'measure': 'Right heart dysfunction', 'timeFrame': '3 mouths', 'description': 'P-V Curve of curve（cmH2O）'}, {'measure': 'Right heart dysfunction', 'timeFrame': '15 days', 'description': 'Duration of tracheal intubation（d)'}, {'measure': 'Right heart dysfunction', 'timeFrame': '15 days', 'description': 'P-V Curve of curve'}, {'measure': 'Right heart dysfunction', 'timeFrame': '15 days', 'description': 'TAPSE'}, {'measure': 'Right heart dysfunction', 'timeFrame': '3 mouths', 'description': 'TAPSE'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Right Heart Insufficiency', 'Tricuspid Regurgitation']}, 'referencesModule': {'references': [{'pmid': '24698557', 'type': 'RESULT', 'citation': 'Ye Y, Desai R, Vargas Abello LM, Rajeswaran J, Klein AL, Blackstone EH, Pettersson GB. Effects of right ventricular morphology and function on outcomes of patients with degenerative mitral valve disease. J Thorac Cardiovasc Surg. 2014 Nov;148(5):2012-2020.e8. doi: 10.1016/j.jtcvs.2014.02.082. Epub 2014 Mar 1.'}, {'pmid': '23487435', 'type': 'RESULT', 'citation': 'Le Tourneau T, Deswarte G, Lamblin N, Foucher-Hossein C, Fayad G, Richardson M, Polge AS, Vannesson C, Topilsky Y, Juthier F, Trochu JN, Enriquez-Sarano M, Bauters C. Right ventricular systolic function in organic mitral regurgitation: impact of biventricular impairment. Circulation. 2013 Apr 16;127(15):1597-608. doi: 10.1161/CIRCULATIONAHA.112.000999. Epub 2013 Mar 13.'}, {'pmid': '33559474', 'type': 'RESULT', 'citation': 'Towheed A, Sabbagh E, Gupta R, Assiri S, Chowdhury MA, Moukarbel GV, Khuder SA, Schwann TA, Bonnell MR, Cooper CJ, Khouri S. Right Ventricular Dysfunction and Short-Term Outcomes Following Left-Sided Valvular Surgery: An Echocardiographic Study. J Am Heart Assoc. 2021 Feb 16;10(4):e016283. doi: 10.1161/JAHA.120.016283. Epub 2021 Feb 9.'}, {'pmid': '33722059', 'type': 'RESULT', 'citation': 'Purmah Y, Lei LY, Dykstra S, Mikami Y, Cornhill A, Satriano A, Flewitt J, Rivest S, Sandonato R, Seib M, Lydell CP, Howarth AG, Heydari B, Merchant N, Bristow M, Fine N, Gaztanaga J, White JA. Right Ventricular Ejection Fraction for the Prediction of Major Adverse Cardiovascular and Heart Failure-Related Events: A Cardiac MRI Based Study of 7131 Patients With Known or Suspected Cardiovascular Disease. Circ Cardiovasc Imaging. 2021 Mar;14(3):e011337. doi: 10.1161/CIRCIMAGING.120.011337. Epub 2021 Mar 16.'}, {'pmid': '34294396', 'type': 'RESULT', 'citation': 'Kresoja KP, Rommel KP, Lucke C, Unterhuber M, Besler C, von Roeder M, Schober AR, Noack T, Gutberlet M, Thiele H, Lurz P. Right Ventricular Contraction Patterns in Patients Undergoing Transcatheter Tricuspid Valve Repair for Severe Tricuspid Regurgitation. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1551-1561. doi: 10.1016/j.jcin.2021.05.005.'}]}, 'descriptionModule': {'briefSummary': '\\"Bicuspid aortic stenosis represents the most prevalent form of cardiac valve disease, primarily resulting from degenerative alterations and rheumatic conditions that disrupt mitral valve function. This dysfunction exacerbates the hemodynamic burden on the right heart, leading to secondary pulmonary hypertension-a condition uniquely predisposed to myocardial fibrosis. The role of right ventricular (RV) fibrosis in pulmonary hypertension induced by bicuspid aortic stenosis remains an area of active investigation. Modifications in the extracellular matrix collagen network may mitigate excessive dilation of the pressure-overloaded right ventricle; however, fibrosis concurrently compromises cardiac performance. An increasing body of experimental evidence indicates that fibrosis is pivotal in both the onset and progression of right ventricular dysfunction. In cases of secondary pulmonary hypertension, the right ventricle endures a posterior load approximately five times greater than normal, rendering these circumstances an excellent model for examining pressure loading effects on RV structure. Notably, severe RV fibrosis persists even after hemodynamic normalization following mitral valve repair; thus, preoperative evaluation of RV fibrosis is essential for optimizing patient outcomes in individuals with secondary pulmonary hypertension attributable to bicuspid aortic stenosis.\n\nIn recent years, myocardial nuclear imaging has gained prominence as a tool for assessing myocardial fibrosis. Initial studies investigated FAPI myocardial nuclear imaging\\'s efficacy in evaluating left ventricular fibrosis among patients with aortic stenosis; subsequent research elucidated its correlation with sudden cardiac death risk in individuals suffering from obstructive hypertrophic cardiomyopathy.\n\nThe comprehension regarding how myocardial fibrosis impacts right ventricular function within patients experiencing pulmonary hypertension due to bicuspid aortic stenosis remains limited. The association between histological RV fibrosis and adverse prognostic indicators as well as outcomes related to right heart failure warrants further exploration.\\"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study was performed in patients with volumetric right ventricular dysfunction. To evaluate the right ventricular function in patients with valvular heart disease and optimize the condition detection and volume therapy in patients with right ventricular dysfunction.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of Tricuspid valve insufficiency; must understand the purpose of the study and signed an informed consent form;\n\nExclusion Criteria:\n\nCombined coronary artery stenosis; Combined with aortic aneurysm related diseases; Patients with congenital heart disease;'}, 'identificationModule': {'nctId': 'NCT06663566', 'briefTitle': 'Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Application of FAPI Visualization in the Assessment of Right Ventricular Dysfunction Due to Volume Overload', 'orgStudyIdInfo': {'id': 'KS2024071'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high-FAPI+', 'description': 'FAPI Nuclear Medicine Cardiac Imaging stronge Positive" in English.', 'interventionNames': ['Diagnostic Test: Diagnose the patient's right heart function as well as right heart fibrosis']}, {'label': 'low-FAPI+', 'description': 'FAPI Nuclear Medicine Cardiac Imaging Weak Positive" in English.', 'interventionNames': ['Diagnostic Test: Diagnose the patient's right heart function as well as right heart fibrosis']}, {'label': 'No FAPI+', 'description': 'FAPI nuclear medicine cardiac imaging negative', 'interventionNames': ['Other: Diagnose the patients right heart function as well as right heart fibrosis']}], 'interventions': [{'name': 'Diagnose the patients right heart function as well as right heart fibrosis', 'type': 'OTHER', 'description': 'Diagnose the patients right heart function as well as right heart fibrosis', 'armGroupLabels': ['No FAPI+']}, {'name': 'Diagnose the patient's right heart function as well as right heart fibrosis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnose the patient\\'s right heart function as well as right heart fibrosis', 'armGroupLabels': ['high-FAPI+']}, {'name': 'Diagnose the patient's right heart function as well as right heart fibrosis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnose the patient\\'s right heart function as well as right heart fibrosis', 'armGroupLabels': ['low-FAPI+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'FAPI', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor, Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Vessel Disease, Beijing 100029, China', 'investigatorFullName': 'Xiaozheng Zhou', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}