Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT02865733
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-05-10', 'releaseDate': '2023-04-17'}], 'estimatedResultsFirstSubmitDate': '2023-04-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C427248', 'term': 'treprostinil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end point is a composite variable', 'timeFrame': 'the first 48 hours after Remodulin used', 'description': 'consisting of death, failing Fontan or failed Fontan according to high pulmonary vascular resistance'}], 'secondaryOutcomes': [{'measure': 'Change from base line of pulmonary hemodynamic measurements', 'timeFrame': 'baseline and 48 hours', 'description': 'Pp/Ps reduce \\>10% or TPG≤6mmHg.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Remodulin®', 'pulmonary vascular resistance', 'univentricular physiology'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '34430604', 'type': 'DERIVED', 'citation': 'Chen X, Cai XM, Zhang MJ, Xu JH, Li H, Xu ZM. Pharmacokinetics of treprostinil in children with functional single-ventricle pulmonary arterial hypertension: a randomized controlled trial. Ann Transl Med. 2021 Jul;9(14):1163. doi: 10.21037/atm-21-3188.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.', 'detailedDescription': 'PH is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after Fontan operation with univentricular physiology. Mild increase of pulmonary vascular resistance may lead to failure of Fontan circulation. Remodulin® has been approved for the treatment of adults with PH, but little is known about the effects in children with PH after Fontan operation. The study aim is to determine the safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAfter Fontan procedure, the criteria should be met\n\n1. mPAP greater than 15 mmHg\n2. TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis)\n\nExclusion Criteria:\n\nAfter Fontan surgery :\n\n1. Severe arrhythmia led to low cardiac output\n2. Platelets smaller than 50,000\\*109/L and obvious bleeding'}, 'identificationModule': {'nctId': 'NCT02865733', 'briefTitle': 'Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Randomized Single-blind Study of Intravenous Maintenance of Remodulin® for the Treatment of Pulmonary Hypertension After Fontan Operation', 'orgStudyIdInfo': {'id': 'SJTUMS-201607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remodulin Injection', 'description': 'Drug: Remodulin Injection Dosage:5 ng/kg/min-80ng/kg/min(0.15ml/hr-2.4ml/hr) Frequency: intravenous maintenance increase at a rate of 10ng/kg/min (0.3ml/hr)every 30 minutes Durations:48 hours', 'interventionNames': ['Drug: Remodulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Distilled water group', 'description': 'Drug:distilled water Dosage:0.15ml/hr-2.4ml/hr Frequency:increase at a rate of 0.3ml/hr every 30 minutes Durations:48 hours', 'interventionNames': ['Drug: distilled water']}], 'interventions': [{'name': 'Remodulin', 'type': 'DRUG', 'otherNames': ['Treprostinil Injection'], 'description': 'After Fontan operation, the mean pulmonary arterial pressure (mPAP)evaluated by CVP or transpulmonary pressure gradient(TPG) evaluated by Echo will be measured firstly, if the data met the criteria, and the patients were enrolled in the experimental group, the patients would be administrated intravenously of Remodulin® with the beginning of 5ng/kg/min, with the rate of 10ng/kg/min every 30 minutes up to 80ng/kg/min.', 'armGroupLabels': ['Remodulin Injection']}, {'name': 'distilled water', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'After Fontan operation, the mPAP (evaluated by CVP) or TPG (evaluated by Echo) will be measured firstly, if the data met the criteria, and the patients were enrolled in placebo group, then the patients would be administrated intravenously of distilled water with the beginning of 0.15ml/hr, with the rate of 0.3ml/hr every 30 minutes up to 2.45ml/hr.', 'armGroupLabels': ['Distilled water group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhuoming Xu, M.D.,Ph,D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief cadiologist,Director of Cardiac intensive Care Unit', 'investigatorFullName': 'Xu Zhuoming', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-04-17', 'type': 'RELEASE'}, {'date': '2023-05-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Xu Zhuoming, chief cadiologist,Director of Cardiac intensive Care Unit, Shanghai Jiao Tong University School of Medicine'}}}}