Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile in Resistant Hypertensive Subjects
Overview
- Phase
- Phase 4
- Intervention
- Dapagliflozin 10mg
- Conditions
- Hypertension
- Sponsor
- University of Campinas, Brazil
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Change in Systolic Blood Pressure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Rodrigo Modolo
Principal Investigator
University of Campinas, Brazil
Eligibility Criteria
Inclusion Criteria
- •Resistant hypertension and type 2 diabetes diagnoses after a 6-month follow-up
- •Use of metformin therapy
- •Therapy adherence
- •Agree to participate in the research protocol and sign the informed consent form
Exclusion Criteria
- •secondary Hypertension
- •pseudoresistance hypertension (poor medication adherence and white coat hypertension)
- •patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases
- •pregnancy
- •autoimmune diseases
Arms & Interventions
Dapagliflozin
Dapagliflozin 10mg daily for 12 weeks.
Intervention: Dapagliflozin 10mg
Dapagliflozin
Dapagliflozin 10mg daily for 12 weeks.
Intervention: Glibenclamide 5Mg Tablet
Glibenclamide
Glibenclamide 5mg daily for 12 weeks.
Intervention: Dapagliflozin 10mg
Glibenclamide
Glibenclamide 5mg daily for 12 weeks.
Intervention: Glibenclamide 5Mg Tablet
Outcomes
Primary Outcomes
Change in Systolic Blood Pressure
Time Frame: Baseline and 12 weeks
Change in Office Systolic Blood Pressure after 12 weeks of treatment
Secondary Outcomes
- Change in arterial stiffness(Baseline and 12 weeks)
- Change in left ventricular hypertrophy(Baseline and 12 weeks)
- Change in Ambulatory Systolic Blood Pressure(Baseline and 12 weeks)
- Change in weight(Baseline and 12 weeks)
- Change in microalbuminuria(Baseline and 12 weeks)