Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT06037434
Status:
UNKNOWN
Last Update Posted:
2023-09-15
First Post:
2023-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002216', 'term': 'Captopril'}, {'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D000077786', 'term': 'Torsemide'}], 'ancestors': [{'id': 'D011392', 'term': 'Proline'}, {'id': 'D007098', 'term': 'Imino Acids'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the recurrence rate of moderate to severe mitral valve regurgitation', 'timeFrame': 'after 12 months of treatment', 'description': 'During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.'}], 'secondaryOutcomes': [{'measure': 'Improvement in symptoms', 'timeFrame': 'after 12 months of treatment', 'description': 'Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms.'}, {'measure': 'Change in left ventricular ejection fraction', 'timeFrame': 'after 12 months of treatment', 'description': 'Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.'}, {'measure': 'Change in left ventricular end-diastolic diameter', 'timeFrame': 'after 12 months of treatment', 'description': 'Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.'}, {'measure': 'NT-proBNP level', 'timeFrame': 'after 12 months of treatment', 'description': 'The trend in NT-proBNP levels.'}, {'measure': 'Incidence rate of drug adverse reactions', 'timeFrame': 'after 12 months of treatment', 'description': 'The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congenital heart disease', 'mitral regurgitation', 'drug therapy'], 'conditions': ['Congenital Mitral Insufficiency']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients with mild to moderate mitral valve regurgitation.\n\nThe main questions it aims to answer are:\n\n* Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation?\n* Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a one-year course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 3 months, 6 months, and 12 months after treatment commencement.\n\nResearchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 12 months of treatment, is lower in the former than in the latter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children under the age of 14 with moderate to severe mitral valve regurgitation, without contraindications for mitral valve repair, and without an immediate need for surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\< 14 years old\n* had not undertake mitral valve surgery before\n* moderate to severe mitral regurgitation\n\nExclusion Criteria:\n\n* moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery\n* concommitant with mitral stenosis\n* ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery)\n* Barlow syndrome\n* dysplasia of mitral leaflet\n* complete/Partial endocardial cushion defect\n* common atrioventricular valve\n* atrioventricular common channel\n* cardiomyopathy\n* other mitral valve surgery contraindications\n* moderate to severe mitral regurgitation requires mitral valve surgery'}, 'identificationModule': {'nctId': 'NCT06037434', 'briefTitle': 'Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Drug Therapy for Pediatric Mitral Regurgitation', 'orgStudyIdInfo': {'id': '2022-GSP-GG-19-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Modified Drug Therapy Group', 'description': 'Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).', 'interventionNames': ['Drug: Captopril Tablets', 'Drug: Metoprolol Oral Tablet', 'Drug: Spironolactone Tablets', 'Drug: Torsemide Tablets', 'Drug: Potassium citrate powder']}, {'label': 'the Traditional Drug Therapy Group', 'description': 'Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).', 'interventionNames': ['Drug: Torsemide Tablets', 'Drug: Potassium citrate powder']}], 'interventions': [{'name': 'Captopril Tablets', 'type': 'DRUG', 'description': '0.3mg/kg, tid', 'armGroupLabels': ['Modified Drug Therapy Group']}, {'name': 'Metoprolol Oral Tablet', 'type': 'DRUG', 'description': '0.2mg/kg, bid', 'armGroupLabels': ['Modified Drug Therapy Group']}, {'name': 'Spironolactone Tablets', 'type': 'DRUG', 'description': '2-4mg/kg, bid', 'armGroupLabels': ['Modified Drug Therapy Group']}, {'name': 'Torsemide Tablets', 'type': 'DRUG', 'description': '0.2-0.5mg/mg, bid', 'armGroupLabels': ['Modified Drug Therapy Group', 'the Traditional Drug Therapy Group']}, {'name': 'Potassium citrate powder', 'type': 'DRUG', 'description': '0.06g/kg, tid', 'armGroupLabels': ['Modified Drug Therapy Group', 'the Traditional Drug Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shoujun Li, MD', 'role': 'CONTACT', 'email': 'drlishoujunfw@163.com', 'phone': '+86 13501071589'}], 'facility': 'Fuwai hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kai Ma, PhD', 'role': 'CONTACT', 'email': 'drmakaifw@yahoo.com', 'phone': '+86 15901428497'}, {'name': 'Zheng Dou, PhD', 'role': 'CONTACT', 'email': 'drdouzheng@163.com', 'phone': '+86 18810673618'}], 'overallOfficials': [{'name': 'Shoujun Li, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, {'name': "Children's Hospital of Chongqing Medical University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Congenital Heart Surgery Center', 'investigatorFullName': 'Shoujun Li', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}