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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
16
Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
University of Campinas (UNICAMP)
Campinas, São Paulo, Brazil
Change in Systolic Blood Pressure
Change in Office Systolic Blood Pressure after 12 weeks of treatment
Time frame: Baseline and 12 weeks
Change in Ambulatory Systolic Blood Pressure
Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment
Time frame: Baseline and 12 weeks
Change in weight
Change in body weight
Time frame: Baseline and 12 weeks
Change in arterial stiffness
Change in arterial stiffness measured by Sphygmocor device
Time frame: Baseline and 12 weeks
Change in left ventricular hypertrophy
Change in left ventricular hypertrophy measured by Echocardiogram
Time frame: Baseline and 12 weeks
Change in microalbuminuria
Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio
Time frame: Baseline and 12 weeks
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