Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 5:44 AM
Study NCT ID:
NCT01485757
Status:
TERMINATED
Last Update Posted:
2017-01-10
First Post:
2011-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective L-arginine Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Technical difficulty with Endo-PAT machine', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-09', 'studyFirstSubmitDate': '2011-11-29', 'studyFirstSubmitQcDate': '2011-12-02', 'lastUpdatePostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine.', 'timeFrame': 'baseline and 12 weeks', 'description': 'Endothelial function will be assessed at baseline as well as after a 12 week treatment course of L-arginine. A final measurement will be made following a 12 week washout period.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in serum levels of oxidative stress markers', 'timeFrame': 'baseline and 12 weeks', 'description': 'Serum markers of oxidative stress will be measured at baseline and after a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period.'}, {'measure': 'Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine', 'timeFrame': 'baseline and 12 weeks', 'description': 'Exercise tolerance will be assessed with a 6 minute walk at baseline and following a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['patients'], 'conditions': ['Heart Transplant']}, 'descriptionModule': {'briefSummary': 'HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and exercise tolerance will be abnormal in the population of young heart transplant patients at baseline, and that each will show a trend towards improvement following a 12 week course of oral L-arginine, with regression towards the baseline following the 12 week washout period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* University of Michigan Pediatric Heart Transplant Clinic patient.\n* Greater than or equal to 8 years of age.\n* Heart transplant between 1 and 8 years prior to enrollment in the study\n\nExclusion Criteria:\n\n* Relative hypotension for age\n* Refusal to participate\n* Inability to cooperate with Endo-PAT testing\n* Pregnant or nursing women.\n* Insulin dependent diabetes'}, 'identificationModule': {'nctId': 'NCT01485757', 'briefTitle': 'Prospective L-arginine Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Effect of Chronic Oral L-arginine Supplementation on Peripheral Endothelial Function and Exercise Tolerance in a Population of Young Heart Transplant Patients.', 'orgStudyIdInfo': {'id': 'HUM00035716'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-arginine', 'interventionNames': ['Drug: L-arginine']}], 'interventions': [{'name': 'L-arginine', 'type': 'DRUG', 'description': 'All study subjects will be treated with a 12 week (11-13 week) course of oral L-arginine at a dose of 6 g per day, divided into morning and evening doses of 3 g (3 1000 mg capsules or caplets).', 'armGroupLabels': ['L-arginine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Pediatric Heart Transplant Clinic', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Josh Friedland-Little, MD', 'investigatorAffiliation': 'University of Michigan'}}}}