Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-27 @ 1:51 PM
Study NCT ID:
NCT06039592
Status:
UNKNOWN
Last Update Posted:
2023-09-15
First Post:
2023-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair
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': 164}, 'targetDuration': '6 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': '2023-09-09', 'studyFirstSubmitDate': '2023-09-09', 'studyFirstSubmitQcDate': '2023-09-09', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-15', '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': 'Improvement in left ventricular function', 'timeFrame': 'after 12 months of treatment', 'description': 'Based on the echocardiogram, measurements are taken for left ventricular ejection fraction, left ventricular fractional shortening, left ventricular end-diastolic diameter, left ventricular end-diastolic volume, left ventricular end-systolic diameter, and left ventricular end-systolic volume.'}, {'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', 'mitral valve repair postoperative', '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 after mitral repair.\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 after mitral repair?\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 6-months 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 1 month, 3 months, and 6 months after treatment commencement. Researchers 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 6 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 after mitral valve repair surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* under 14 years old\n* after mitral valve repair\n\nExclusion Criteria:\n\n* Patients with heart failure requiring ventricular assist or cardiac synchronization therapy\n* Patients with severe pulmonary hypertension (pulmonary arterial pressure \\>6 Wood·U)\n* Patients with severe liver and kidney failure\n* Patients who are allergic to related medications\n* Patients with symptomatic hypotension who cannot tolerate related drugs'}, 'identificationModule': {'nctId': 'NCT06039592', 'briefTitle': 'Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair', '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 in Improving Left Ventricular Function After Mitral Repair', 'orgStudyIdInfo': {'id': '2022-GSP-GG-19-3'}}, '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': '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', 'Traditional Drug Therapy Group']}, {'name': 'Potassium citrate powder', 'type': 'DRUG', 'description': '0.06g/kg, tid', 'armGroupLabels': ['Modified Drug Therapy Group', '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'}}}}