Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-05 @ 6:31 PM
Study NCT ID:
NCT02810132
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in LV myocardial efficiency', 'timeFrame': 'Baseline and 3 months', 'description': 'LV myocardial efficiency is the ratio between stroke work and myocardial oxygen consumption, which are measured with echocardiography and \\[11C\\]-acetate PET.'}], 'secondaryOutcomes': [{'measure': 'Left ventricular global longitudinal strain during peak exercise', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Myocardial oxygen consumption', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Myocardial perfusion at rest', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'LV myocardial function evaluated by LVEF and diastolic function', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'LV mass', 'timeFrame': 'Baseline and 3 months'}, {'measure': '6 minute walking distance', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Changes in body composition', 'timeFrame': 'Baseline and 3 months', 'description': 'Measured by bioelectrical impedance analysis (BIA)'}, {'measure': 'Maximum oxygen consumption', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Degree of insulin resistance', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Minnesota living with heart failure questionnaire', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'NT-proBNP', 'timeFrame': 'Baseline and 3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure, Systolic']}, 'referencesModule': {'references': [{'pmid': '32770520', 'type': 'DERIVED', 'citation': 'Larsen AH, Wiggers H, Dollerup OL, Jespersen NR, Hansson NH, Frokiaer J, Brosen K, Norrelund H, Botker HE, Moller N, Jessen N. Metformin Lowers Body Weight But Fails to Increase Insulin Sensitivity in Chronic Heart Failure Patients without Diabetes: a Randomized, Double-Blind, Placebo-Controlled Study. Cardiovasc Drugs Ther. 2021 Jun;35(3):491-503. doi: 10.1007/s10557-020-07050-5. Epub 2020 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the effects of metformin treatment on myocardial efficiency in heart failure patients. 36 patients will be randomized to three months of metformin or placebo treatment in addition to their regular therapy.\n\nHypothesis: Treatment with metformin in patients with heart failure has direct or indirect beneficial effects on left ventricular myocardial oxidative metabolism, myocardial efficiency and contractile function.', 'detailedDescription': 'Background: Heart failure (HF) is a common disease and diabetes/insulin resistance are present in approximately 50 % of HF patients. Metformin is the most commonly prescribed oral anti-diabetic drug, and registry and experimental studies show beneficial effects of metformin in HF, but randomized trials are needed.\n\nObjectives: To investigate if treatment with metformin in patients with HF has beneficial effects on myocardial efficiency,\n\nDesign: A randomized, double-blind, placebo-controlled, single-center design. 36 patients with systolic heart failure will be randomized to either metformin (N = 18) or placebo (N= 18) for 3 months.\n\nMethods: Patients will undergo echocardiography at rest and during exercise along with \\[11C\\]-acetate PET.\n\nPrimary outcome parameter is changes in myocardial external efficiency from visit 1 to 3 months of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic heart failure uptitrated to recommended or maximally tolerated dose of ACE-I/ARB (unless contraindicated) and beta-blocker (unless contraindicated). If indicated, an aldosterone receptor antagonist should be given (unless contraindicated). An ICD and/or CRT should be implanted, if indicated. Patients with a CRT device should be treated for \\> 3 months.\n* LVEF \\< 45%\n* NYHA-class II, III or IV\n* Relatively preserved renal function (eGFR \\> 30 ml/min)\n* Ability to understand the written patient information and to give informed consent\n* Negative urine-HCG for women of childbearing potential\n* Patients must have insulin resistance, defined as 1 or more of the following criteria:\n\n 1. HbA1c 5.5 - 6.4% (37 - 47 mmol/mol) within the last 12 months prior to enrolment\n 2. Impaired fasting glucose (IFG): Fasting P-glucose 5.6 - 6.9 mmol/l within 12 months prior to enrolment (patient in stable condition)\n 3. Impaired glucose tolerance (IGT) if OGTT has been performed at any time prior to enrolment: Fasting P-glucose \\< 7.0 mmol/l and 2 hour P-glucose 7.8 -11.0 mmol/l\n\nExclusion Criteria:\n\n* Metformin treatment within the last 3 months\n* Known allergy to metformin or major side effects to metformin treatment\n* Acute myocardial infarction, unstable angina or revascularization \\< 3 months at the time of randomization\n* Planned coronary revascularization\n* Significant, uncorrected cardiac valve disease\n* Cardiac arrest or life threatening ventricular arrhythmias within the last 3 months (unless treated with an ICD)\n* Atrial fibrillation with poorly controlled ventricular rate at rest (\\> 100 beats/min)\n* Hypertrophic or restrictive cardiomyopathy, infiltrative or storage myocardial disease, active myocarditis, or pericardial disease.\n* Planned major surgery\n* Female patients who are pregnant, nursing, or of childbearing potential while not practicing effective chemical contraceptive methods (i.e. oral, implanted, injectable, or transdermal contraceptive hormones; intrauterine device)\n* Age \\< 18 years\n* Current abuse of alcohol or drugs\n* Cancer, with a life-expectancy of less than 2 years\n* Stroke within the last 6 months\n* Liver disease with P-ALAT \\>3 times upper normal limit (it is possible to repeat this measurement once within a month)\n* Significant comorbidity or issue that makes the patient unsuitable for participation as judged by the investigator\n* Participation in another study involving long-term medical intervention (participation in device studies is allowed)'}, 'identificationModule': {'nctId': 'NCT02810132', 'acronym': 'METRONOME', 'briefTitle': 'Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Effects of Metformin Treatment on Myocardial Efficiency in Patients With Heart Failure: A Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': '2015-588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'Drug: Metformin Target dose: 1000 mg x 2 (if eGFR 30-60 ml/min: 500 mg x 2) Other name: Glucophage XR 500', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage XR 500'], 'description': 'See above', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'See above', 'armGroupLabels': ['Placebo']}]}, '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': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant, associate professor, PhD, DMSc', 'investigatorFullName': 'Henrik Wiggers', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}