Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 11:46 PM
Study NCT ID:
NCT07050706
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-03
First Post:
2025-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between Serum PRMT5 Level and Cardiac Ultrasound Indicators in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum PRMT5 level at baseline', 'timeFrame': 'Baseline (day of informed consent agreement and blood sampling)', 'description': 'Serum PRMT5 level is analysed at the day of informed consent agreement and blood sampling'}, {'measure': 'LVIDs level at baseline', 'timeFrame': 'Baseline', 'description': 'Left ventricular internal diameter at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination'}, {'measure': 'LVIDd level at baseline', 'timeFrame': 'Baseline', 'description': 'Left ventricular internal diameter at diastolic state is measured at the day of informed consent agreement and cardiac ultrasound examination'}, {'measure': 'LVPWs level at baseline', 'timeFrame': 'Baseline', 'description': 'left ventricular posterior wall at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination'}, {'measure': 'LVPWd level at baseline', 'timeFrame': 'Baseline', 'description': 'left ventricular posterior wall at diastole state is measured at the day of informed consent agreement and cardiac ultrasound examination'}, {'measure': 'IVSTs at baseline', 'timeFrame': 'Baseline', 'description': 'Interventricular septum at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination'}, {'measure': 'IVSTd at baseline', 'timeFrame': 'Baseline', 'description': 'Interventricular septum at diastolic state is measured at the day of informed consent agreement and cardiac ultrasound examination'}, {'measure': 'EF at baseline', 'timeFrame': 'Baseline', 'description': 'Ejection fraction is calculated according to the formula below:\n\n1. EF=(LVEDV-LVESV)/LVEDV\\*100%;\n2. LVEDV=(7.0\\*LVIDd\\^3)/(2.4+LVIDd)\n3. LVESV=(7.0\\*LVIDs\\^3)/(2.4+LVIDs)'}, {'measure': 'FS at baseline', 'timeFrame': 'Baseline', 'description': 'Fractional shortening is calculated based on the formula below:\n\nFS=(LVIDd-LVIDs)/LVIDd\\*100%'}, {'measure': 'LVMi at baseline', 'timeFrame': 'Baseline', 'description': 'Left ventricular mass index is calculated according to the formula below:\n\n1. LVMi(g/m\\^2)=LVM/BSA;\n2. LVM(g)=LVM=0.8×1.04×\\[(LVIDd+IVSd+LVPWd)\\^3-LVIDd\\^3\\]+0.6;\n3. BSA(m\\^2)=0.007184×W\\^0.425×H\\^0.725 (W: Weight, kg; H: Height, cm)'}, {'measure': 'RWT at baseline', 'timeFrame': 'Baseline', 'description': 'Relative wall thickness is calculated according to the formula below:\n\nRWT=2\\*(IVSd+LVPWd)/LVIDd'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRMT5', 'Heart failure', 'cardiac function and cardiac structure'], 'conditions': ['Heart Failure, Systolic']}, 'descriptionModule': {'briefSummary': 'Pathological cardiac hypertrophy is characterized by abnormal cardiomyocyte metabolism, reduced myocardial contractility, and dysregulated synthesis of myocardial contractile proteins. This pathological process leads to progressive impairment of cardiac function and ultimately progresses to heart failure. Previous studies have demonstrated that PRMT5 exerts a significant inhibitory effect on heart failure, yet its clinical significance in the context of heart failure remains undefined. In this study, we hypothesized that serum PRMT5 may serve as a biomarker to predict cardiac structural parameters and functional indices. Therefore, we aim to analyse the correlation between serum PRMT5 levels and the following parameters-LVPWs, LVPWd, LVIDs, LVIDd, IVSTs, IVSTd, EF, FS, LVMi and RWT on the first day when participants are enrolled in this study.', 'detailedDescription': 'The aim of this study is to collect blood samples from both healthy controls and heart failure patients and to clarify the correlation between serum PRMT5 levels on the first day of enrollment and cardiac ultrasound indicators. Serum PRMT5 levels are measured by means of enzyme-linked immunosorbent assay (ELISA). Left ventricular posterior wall thickness at end-systole (LVPWs), Left ventricular posterior wall thickness at end-diastole (LVPWd), left ventricular internal diameter at end-systole (LVIDs), left ventricular internal diameter at end-diastole (LVIDd), interventricular septum at end-systole (IVSTs) and interventricular septal septum at end-diastole (IVSTd) are measured on the first day of enrollment via echocardiography. Ejection fraction (EF), fractional shortening (FS), left ventricular mass index (LVMi), and relative wall thickness (RWT) are subsequently calculated based on LVIDd, LVPWd, and IVSTd values. Finally, the correlations between serum PRMT5 levels and the following indicators are analyzed: LVPWs, LVPWd, LVIDs, LVIDd, IVSTs, IVSTd, EF, FS, LVMi and RWT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study evaluated whether serum PRMT5 levels could predict echocardiographic parameters in healthy controls and heart failure patients. A total of 50 participants in the healthy group and 50 in the heart failure group completed the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy group: Aged ≥18 years (both sexes), systolic blood pressure (SBP) ≤120 mmHg and diastolic blood pressure (DBP) ≤80 mmHg, no history of cardiovascular diseases, ejection fraction (EF) ≥50%.\n\nHeart failure group: Aged ≥18 years (both sexes), EF ≤50%.\n\nExclusion Criteria:\n\n* Exclusion criteria for healthy people: people with other underlying diseases or congenital diseases are not included in the study.\n* Exclusion criteria for patients with heart failure: patients with heart failure other metabolic diseases or congenital diseases were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07050706', 'briefTitle': 'The Correlation Between Serum PRMT5 Level and Cardiac Ultrasound Indicators in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong-Shenzhen Hospital'}, 'officialTitle': 'Study on the Correlation Between Serum PRMT5 Level and Cardiac Structural and Functional Indicators in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'PRMT5 and Heart Failure'}, 'secondaryIdInfos': [{'id': '82300446', 'type': 'OTHER_GRANT', 'domain': 'National Science Foundation of China'}, {'id': '2022A1515111093', 'type': 'OTHER_GRANT', 'domain': 'Guangdong Basic and Applied Basic Research Foundation'}, {'id': 'RCBS20231211090745071', 'type': 'OTHER_GRANT', 'domain': 'Shenzhen Science and Technology Program'}]}, 'contactsLocationsModule': {'locations': [{'zip': '518033', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'the University of Hongkong-Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'overallOfficials': [{'name': 'Assistant research fellow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of HongKong-Shenzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong-Shenzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant research fellow', 'investigatorFullName': 'Cai Sidong', 'investigatorAffiliation': 'The University of Hong Kong-Shenzhen Hospital'}}}}