Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT01101620
Status:
COMPLETED
Last Update Posted:
2011-01-20
First Post:
2010-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}], 'ancestors': [{'id': 'D006835', 'term': 'Hydrazones'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011724', 'term': 'Pyridazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-19', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2010-04-09', 'lastUpdatePostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves', 'timeFrame': 'Multiple measurements within 4 hours after administration of study medication'}, {'measure': 'Fatiguability of the diaphragm', 'timeFrame': 'Multiple measurements within 4 hours after administration of study medication'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Respiratory Muscle Function']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n\nExclusion Criteria:\n\n* use of any prescript medication\n* chronic hiccups\n* pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including diabetes and auto-immune diseases.\n* pre-existent lung disease\n* pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)\n* pregnancy, breast feeding\n* upper airway / esophageal pathology\n* phrenic nerve lesions\n* any metals in body (pacemaker, splinters, metal stiches)'}, 'identificationModule': {'nctId': 'NCT01101620', 'acronym': 'LSD1', 'briefTitle': 'Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Nijmegen'}, 'officialTitle': 'Pilot Study on the Effects of Levosimendan on in Vivo Respiratory Muscle Function in Healthy Subjects', 'orgStudyIdInfo': {'id': 'Levo1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levosimendan', 'interventionNames': ['Drug: Levosimendan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Levosimendan']}], 'interventions': [{'name': 'Levosimendan', 'type': 'DRUG', 'armGroupLabels': ['Levosimendan', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Leo Heunks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Nijmegen'}, {'name': 'Jonne Doorduin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Nijmegen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Nijmegen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Leo Heunks', 'oldOrganization': 'University Medical Center Nijmegen'}}}}