Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10mg daily for 12 weeks. |
|
| Glibenclamide | Active Comparator | Glibenclamide 5mg daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg | Drug | Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Change in Office Systolic Blood Pressure after 12 weeks of treatment | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ambulatory Systolic Blood Pressure | Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment | Baseline and 12 weeks |
| Change in weight | Change in body weight |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Modolo, MD, PhD | University of Campinas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Campinas (UNICAMP) | Campinas | São Paulo | 13083970 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two-way crossover design
Not provided
Not provided
Not provided
|
| Glibenclamide 5Mg Tablet | Drug | Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks |
|
|
| Baseline and 12 weeks |
| Change in arterial stiffness | Change in arterial stiffness measured by Sphygmocor device | Baseline and 12 weeks |
| Change in left ventricular hypertrophy | Change in left ventricular hypertrophy measured by Echocardiogram | Baseline and 12 weeks |
| Change in microalbuminuria | Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio | Baseline and 12 weeks |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D006332 | Cardiomegaly |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D005905 | Glyburide |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided