Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-31 @ 9:47 AM
Study NCT ID:
NCT03331861
Status:
TERMINATED
Last Update Posted:
2024-07-18
First Post:
2017-11-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metformin in Heart Failure Without Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bmf2002@cumc.columbia.edu', 'phone': '212-305-5755', 'title': 'Barry Fine, MD', 'organization': 'Columbia University Irving Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was terminated early, data was unblinded but not analyzed due to low enrollment and lack of statistical power.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Metformin', 'description': 'Metformin for 6 months\n\nMetformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matched placebo for 6 months\n\nPlacebo: Similar dosing regime as active comparator', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Minute Ventilation to Carbon Dioxide Production (VE/VCO2) Slope', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin for 6 months\n\nMetformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo for 6 months\n\nPlacebo: Similar dosing regime as active comparator'}], 'timeFrame': 'Baseline and 6 months', 'description': 'The VO2 change outcomes will be assessed for normality using standard visual assessments (Q-Q plots and histograms) and statistical tests (Kolmogorov-Smirnov). VE/VCO2 slope change will be calculated.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Visual Analog Scale (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin for 6 months\n\nMetformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo for 6 months\n\nPlacebo: Similar dosing regime as active comparator'}], 'timeFrame': 'Baseline and 6 months', 'description': 'Dyspnea Assessment. 100mm line scale ranging from 0 (worse imaginable breathing) to 100 (best imaginable breathing).', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.'}, {'type': 'SECONDARY', 'title': 'Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin for 6 months\n\nMetformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo for 6 months\n\nPlacebo: Similar dosing regime as active comparator'}], 'timeFrame': 'Baseline, 6 months', 'description': "A validated patient-oriented measure of the adverse effects of heart failure on a patient's life. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.", 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.'}, {'type': 'SECONDARY', 'title': 'Peak Myocardial Oxygen Consumption (VO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin for 6 months\n\nMetformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo for 6 months\n\nPlacebo: Similar dosing regime as active comparator'}], 'timeFrame': 'Baseline, 6 months', 'description': 'Oxygen consumption (VO2) (ml/min) will be measured on a breath by breath basis. Peak VO2 will be computed using standard methods.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.'}, {'type': 'SECONDARY', 'title': 'Heart Failure Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin for 6 months\n\nMetformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo for 6 months\n\nPlacebo: Similar dosing regime as active comparator'}], 'timeFrame': 'Up to 6 months', 'description': 'The number of hospitalizations recorded during the study will be tallied.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin', 'description': 'Metformin for 6 months\n\nMetformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matched placebo for 6 months\n\nPlacebo: Similar dosing regime as active comparator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '2 out of 6 participants screen failed and no further information was collected or analyzed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metformin', 'description': 'Metformin for 6 months\n\nMetformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matched placebo for 6 months\n\nPlacebo: Similar dosing regime as active comparator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-03', 'size': 1047775, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-19T10:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2017-11-01', 'resultsFirstSubmitDate': '2022-08-20', 'studyFirstSubmitQcDate': '2017-11-01', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-17', 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Minute Ventilation to Carbon Dioxide Production (VE/VCO2) Slope', 'timeFrame': 'Baseline and 6 months', 'description': 'The VO2 change outcomes will be assessed for normality using standard visual assessments (Q-Q plots and histograms) and statistical tests (Kolmogorov-Smirnov). VE/VCO2 slope change will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Analog Scale (VAS) Score', 'timeFrame': 'Baseline and 6 months', 'description': 'Dyspnea Assessment. 100mm line scale ranging from 0 (worse imaginable breathing) to 100 (best imaginable breathing).'}, {'measure': 'Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ) Score', 'timeFrame': 'Baseline, 6 months', 'description': "A validated patient-oriented measure of the adverse effects of heart failure on a patient's life. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses."}, {'measure': 'Peak Myocardial Oxygen Consumption (VO2)', 'timeFrame': 'Baseline, 6 months', 'description': 'Oxygen consumption (VO2) (ml/min) will be measured on a breath by breath basis. Peak VO2 will be computed using standard methods.'}, {'measure': 'Heart Failure Hospitalizations', 'timeFrame': 'Up to 6 months', 'description': 'The number of hospitalizations recorded during the study will be tallied.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'A pilot clinical research study that will assess the use of the medication metformin for heart failure in patients who are not diabetic and have no evidence of insulin resistance.', 'detailedDescription': 'Patients (n=50) will received either the study drug metformin or placebo for 4 months. During the study, the patients will undergo extensive testing that will include symptom assessment, exercise capacity, echocardiography, cardiac PET imaging and blood tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18yrs old\n* Patients with chronic heart failure (defined as \\>6 months duration) 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* Reduced ejection fraction defined as LVEF ≤ 35%\n* NYHA-class II or III with stable symptoms for at least the past 3 months\n* Renal Function by eGFR ≥ 45 ml/min (MDRD equation) in accordance with FDA guidance on metformin use in CKD(24)\n* Non-insulin resistant defined as a fasting insulin resistance index, or HOMA-IR of \\<2.7.\n* Non-diabetic defined as a HgbA1c \\<6.0\n\nExclusion Criteria:\n\n* Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)\n* Known allergy to metformin or major side effects to metformin treatment\n* Concomitant use of a carbonic anhydrase inhibitor (such as acetazolamide or topirafmate)\n* Heart Failure Hospitalizations in the past 3 months (primary diagnosis on admission is heart failure)\n* Acute myocardial infarction, unstable angina or revascularization with prior 3 months at the time of randomization\n* Planned coronary revascularization, heart surgery, CRT implantation or other intervention during the study period that would potentially affect the function of the heart\n* Significant, uncorrected primary cardiac valve disease, specifically severely stenotic or regurgitant mitral or aortic valves\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 (\\> 110 beats/min)\n* Hypertrophic or restrictive cardiomyopathy, infiltrative or storage myocardial disease, active myocarditis, or pericardial disease.\n* Planned major surgery within the study period\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* Current abuse of alcohol or drugs\n* Life-expectancy of less than 1 year due to co-existing morbid illness\n* Liver disease with ALT or AST \\>3 times upper normal limit (it is possible to repeat this measurement once within a month)\n* Advanced lung disease such as COPD\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': 'NCT03331861', 'acronym': 'Met-HeFT', 'briefTitle': 'Metformin in Heart Failure Without Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Metformin in Heart Failure Without Diabetes', 'orgStudyIdInfo': {'id': 'AAAR5389'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin for 6 months', 'interventionNames': ['Drug: Metformin hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matched placebo for 6 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin hydrochloride', 'type': 'DRUG', 'otherNames': ['Metformin'], 'description': 'Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo Tablet'], 'description': 'Similar dosing regime as active comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Hospital - Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Barry Fine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Barry Fine', 'investigatorAffiliation': 'Columbia University'}}}}