Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-09 @ 1:59 AM
Study NCT ID:
NCT03089333
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2017-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006332', 'term': 'Cardiomegaly'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D005905', 'term': 'Glyburide'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Two-way crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in Office Systolic Blood Pressure after 12 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Change in Ambulatory Systolic Blood Pressure', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment'}, {'measure': 'Change in weight', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in body weight'}, {'measure': 'Change in arterial stiffness', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in arterial stiffness measured by Sphygmocor device'}, {'measure': 'Change in left ventricular hypertrophy', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in left ventricular hypertrophy measured by Echocardiogram'}, {'measure': 'Change in microalbuminuria', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Diabetes Mellitus, Type 2', 'Blood Pressure', 'Obesity', 'Cardiac Hypertrophy', 'Microalbuminuria', 'Vascular Stiffness']}, 'descriptionModule': {'briefSummary': 'New strategies trying to achieve blood pressure control and consequently reduce cardiovascular risk in resistant hypertensive subjects are promising. In this context, the SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a potential drug in order to impact on blood pressure levels, as well as target organ damage and adiposity in this high-risk population.', 'detailedDescription': 'Objective: The investigators aim to assess whether the intervention with the SGLT2 inhibitor -dapaglifozin - reduces PA levels, target organ damage, fat profile and change the adipokines levels in patients with resistant hypertension with DM2. Methods and design: This crossover randomized, double-blind, interventional study controlled by standard therapy will include 20 patients with resistant hypertension and type 2 diabetes, followed in Outpatient Clinic specialized in Resistant Hypertension at clinical Hospital-UNICAMP. They will be randomly assigned into two groups (1) initially treated with dapagliflozin in combination with their usual antihypertensive therapy and metformin, at 12 weeks (n = 10) or group (2) Control initially treated with glibenclamide at a dose of 5mg daily in combination with antihypertensive therapy usual and metformin, at 12 weeks (n = 10). Office ambulatory and home BP measurements; anthropometric measurements, determination of vascular stiffness by pulse wave velocity, echocardiogram, body bioimpedance, enzyme immunoassays for the determination of adipokines, and lab tests to evaluate biochemical parameters will be performed pre- and after the use of both treatments. Glycemic parameters, and weight will be assessed every 4 weeks. Results and conclusion: The use of SGLT2 inhibitor in these patients may provide new strategies for treatment of patients with resistant hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resistant hypertension and type 2 diabetes diagnoses after a 6-month follow-up\n* Use of metformin therapy\n* Therapy adherence\n* Agree to participate in the research protocol and sign the informed consent form\n\nExclusion Criteria:\n\n* secondary Hypertension\n* pseudoresistance hypertension (poor medication adherence and white coat hypertension)\n* patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases\n* pregnancy\n* smoking\n* autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT03089333', 'briefTitle': 'Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile in Resistant Hypertensive Subjects', 'orgStudyIdInfo': {'id': '2016004830'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'description': 'Dapagliflozin 10mg daily for 12 weeks.', 'interventionNames': ['Drug: Dapagliflozin 10mg', 'Drug: Glibenclamide 5Mg Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glibenclamide', 'description': 'Glibenclamide 5mg daily for 12 weeks.', 'interventionNames': ['Drug: Dapagliflozin 10mg', 'Drug: Glibenclamide 5Mg Tablet']}], 'interventions': [{'name': 'Dapagliflozin 10mg', 'type': 'DRUG', 'otherNames': ['FARXIGA®'], 'description': 'Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks', 'armGroupLabels': ['Dapagliflozin', 'Glibenclamide']}, {'name': 'Glibenclamide 5Mg Tablet', 'type': 'DRUG', 'otherNames': ['Glibenclamide'], 'description': 'Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks', 'armGroupLabels': ['Dapagliflozin', 'Glibenclamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13083970', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Campinas (UNICAMP)', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Rodrigo Modolo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campinas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rodrigo Modolo', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}