Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 10:29 PM
Study NCT ID:
NCT02862067
Status:
COMPLETED
Last Update Posted:
2018-07-16
First Post:
2016-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGLT2 Inhibition in Diabetes and Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D054143', 'term': 'Heart Failure, Systolic'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-12', 'studyFirstSubmitDate': '2016-08-01', 'studyFirstSubmitQcDate': '2016-08-05', 'lastUpdatePostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SGLT2 inhibition effects on cardiorespiratory fitness (CRF).', 'timeFrame': '4 weeks', 'description': 'To measure the effects of Empagliflozin on cardiorespiratory fitness in patients with type 2 diabetes and heart failure with reduced ejection fraction or systolic heart failure. The effects on CRF are determined by measuring changes in peak VO2 (mL/kg/min) and the VE/VCO2 slope.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SGLT2', 'type 2 diabetes mellitus', 'systolic heart failure', 'heart failure with reduced ejection fraction'], 'conditions': ['Diabetes Mellitus, Type 2', 'Heart Failure, Systolic']}, 'referencesModule': {'references': [{'pmid': '29603546', 'type': 'RESULT', 'citation': 'Carbone S, Canada JM, Billingsley HE, Kadariya D, Dixon DL, Trankle CR, Buckley LF, Markley R, Vo C, Medina de Chazal H, Christopher S, Buzzetti R, Van Tassell BW, Abbate A. Effects of empagliflozin on cardiorespiratory fitness and significant interaction of loop diuretics. Diabetes Obes Metab. 2018 Aug;20(8):2014-2018. doi: 10.1111/dom.13309. Epub 2018 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.', 'detailedDescription': 'The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic heart failure.\n\nParticipants treated with SGLT2 inhibitor Empagliflozin as standard of care will undergo assessments described below.\n\nThe investigators will measure CRF with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether SGLT2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (VO2)(mL/kg/min) and minute ventilation (VE)/carbon dioxide production (VCO2) slope, powerful independent clinical predictors of mortality in HF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 Diabetes Mellitus and Heart Failure with reduced Ejection Fraction or Systolic Heart Failure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed clinical diagnosis of stable HF (NYHA class II-III) on maximally tolerated HF medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics\n* Reduced left ventricular systolic function (LVEF\\<50%) documented in the prior 12 months\n* Poorly controlled T2DM (HbA1c levels between 6.5% and 10.0%)\n* 18 years old and older.\n\nExclusion Criteria:\n\n* Type I diabetes;\n* Type II diabetes with episodes of severe hypoglycemia \\<50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time);\n* Open label treatment with SGLT2 inhibitors (within the past month);\n* Treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention;\n* Chronic Kidney Disease (GFR\\<45 ml/kg\\*min);\n* Uncontrolled thyroid dysfunction (TSH\\<0.4\\>4.5 mcIU/ml);\n* Pregnancy or of child-bearing potential;\n* Active or recent (within 2 weeks) genital/urinal infection;\n* Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart disease, angina, arterial hypotension (BP systolic \\<90 mmHg), orthostatic arterial hypotension, arterial hypertension (resting BP systolic \\>160 mmHg), atrial fibrillation with rapid ventricular response, severe valvular disease, severe chronic obstructive or restrictive pulmonary disease, moderate- severe anemia (Hgb\\<10 g/dl);\n* Abnormal BP or heart rate response, angina or ECG changes (ischemia or arrhy- thmias) occurring during baseline cardio-pulmonary exercise testing;\n* Chronic use of oral corticosteroids;\n* Inability to give informed consent.'}, 'identificationModule': {'nctId': 'NCT02862067', 'briefTitle': 'SGLT2 Inhibition in Diabetes and Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'SGLT2 Inhibition in Diabetic Patients With Heart Failure With Reduced Ejection Fraction', 'orgStudyIdInfo': {'id': 'HM20007722'}, 'secondaryIdInfos': [{'id': '16MCPRP31100003', 'type': 'OTHER_GRANT', 'domain': 'American Heart Association'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Assessment of cardiorespiratory fitness', 'type': 'OTHER', 'description': 'Assessment of cardiorespiratory fitness'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Salvatore Carbone, PhD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators plan to present the data promptly upon analysis as an abstract to a national meeting and/or a manuscript.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}