Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 8:59 AM
Study NCT ID:
NCT03692234
Status:
UNKNOWN
Last Update Posted:
2021-07-02
First Post:
2018-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homoarginine Supplementation in Patients After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized double-blind placebo controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-09-28', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homoarginine serum concentration', 'timeFrame': 'six month', 'description': 'Normalization of homoarginine serum concentration to levels \\>2.1 umol/L.'}], 'secondaryOutcomes': [{'measure': 'Intima-media thickness', 'timeFrame': 'six month', 'description': 'Intima-media thickness (IMT) measured at both common carotid arteries using an edge detection system. Plaques are defined as protrusion of ≥1.5 mm in common, internal and external carotid artery.'}, {'measure': 'National Institute of Health Stroke Scale', 'timeFrame': 'six month', 'description': 'National Institute of Health Stroke Scale (NIHSS) will be assessed by a neurologist. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) and 4 (maximum impairment). The maximum possible score is 42, with the minimum score being a 0.'}, {'measure': 'Modified Ranking Scale', 'timeFrame': 'six month', 'description': 'Modified Ranking Scale (mRS) is a scale for measuring the degree of disability of a stroke patients. The scale runs from 0 (perfect health) to 6 (death).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['homoarginine'], 'conditions': ['Deficiency; Diet']}, 'referencesModule': {'references': [{'pmid': '27434056', 'type': 'BACKGROUND', 'citation': 'Atzler D, Schonhoff M, Cordts K, Ortland I, Hoppe J, Hummel FC, Gerloff C, Jaehde U, Jagodzinski A, Boger RH, Choe CU, Schwedhelm E. Oral supplementation with L-homoarginine in young volunteers. Br J Clin Pharmacol. 2016 Dec;82(6):1477-1485. doi: 10.1111/bcp.13068. Epub 2016 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ischemic stroke (CT or MRI), high-risk transient ischemic attack (ABCD2-score \\>= 4) or acute central retinal artery occlusion\n* serum homoarginine \\</= 2.1 umol/L\n* signed informed consent\n\nExclusion Criteria:\n\n* no acute stroke\n* serum homoarginine \\> 2.1 umol/L\n* heart failure (NYHA \\> 1)\n* chronic kidney disease (GFR \\<60 mL/min)\n* not competent\n* pregnancy, lactation\n* no or withdrawn signed informed consent'}, 'identificationModule': {'nctId': 'NCT03692234', 'acronym': 'HiS', 'briefTitle': 'Homoarginine Supplementation in Patients After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Homoarginine in Stroke (HiS) Study', 'orgStudyIdInfo': {'id': 'Homoarginine in Stroke'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo capsules containing lactose - oral once weekly administration for six month', 'interventionNames': ['Other: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'homoarginine', 'description': '125 mg L-homoarginine supplement - oral once weekly administration for six month', 'interventionNames': ['Dietary Supplement: 125 mg L-homoarginine']}], 'interventions': [{'name': '125 mg L-homoarginine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'capsules for oral supplementation', 'armGroupLabels': ['homoarginine']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'capsules for oral supplementation', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Chi-un Che, MD', 'role': 'CONTACT'}], 'facility': 'University Medical Center Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Chi-un Choe, MD', 'role': 'CONTACT', 'email': 'cchoe@uke.de', 'phone': '+49407410', 'phoneExt': '22389'}, {'name': 'Edzard Schwedhelm, PhD', 'role': 'CONTACT', 'email': 'schwedhelm@uke.de', 'phone': '+49407410', 'phoneExt': '54891'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}