Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-02 @ 1:45 AM
Study NCT ID:
NCT03122769
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2017-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All 6 subjects allocated to the study will receive 11C-metformin intravenously.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metformin uptake in the failing myocardium', 'timeFrame': '12 months', 'description': 'Cardiac uptake is evaluated through analysis of acquired PET-images.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metformin', 'Heart Failure', 'Organic cation transporter', 'Pharmacogenetics', 'Pharmacokinetics', 'Positron Emission Tomography'], 'conditions': ['Heart Failure, Systolic']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate if metformin is taken up into the failing myocardium. Recent experimental and epidemiological studies have shown beneficial effects of metformin on heart failure. It is unknown whether this effect is direct or indirect.\n\nThe aim of the study is to investigate if metformin is taken up in heart failure using a novel 11C-metformin tracer and positron emission tomography (PET).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic heart failure, Left Ventricular Ejection Fraction \\<45%\n* New York Heart Association (NYHA) class I, II, III\n* Relatively preserved renal function (eGFR \\> 30 ml/min)\n* Ability to understand the written patient information and to give informed consent\n* Negative p-HCG for women of childbearing potential\n\nExclusion Criteria:\n\n* Known allergy to metformin\n* Age \\< 18 years\n* Current abuse of alcohol or drugs'}, 'identificationModule': {'nctId': 'NCT03122769', 'briefTitle': 'Cardiac Uptake of Metformin, Visualized by Positron Emission Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Cardiac Uptake of Metformin and Expression of Metformin Membrane Transporter Proteins in the Human Failing Myocardium', 'orgStudyIdInfo': {'id': '2016-003453-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '11C-metformin', 'description': 'All participants allocated to the study will be included in this arm', 'interventionNames': ['Radiation: 11C-metformin']}], 'interventions': [{'name': '11C-metformin', 'type': 'RADIATION', 'description': '200 MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Positron Emission Tomography', 'armGroupLabels': ['11C-metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Aarhus University Hospital, Department of Cardiology, Palle Juul-Jensens Boulevard 99', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henrik Wiggers', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior consultant, associate professor, MD, PhD, DMSc', 'investigatorFullName': 'Henrik Wiggers', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}