Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Hypertension; Cardiac Hypertrophy; Vascular Stiffness; Microalbuminuria; Obesity; Diabetes Mellitus, Type 2; Blood Pressure

Treatments: Drug: Dapagliflozin 10mg; Drug: Glibenclamide 5Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03089333

2016004830

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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
• smoking
• autoimmune diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Dapagliflozin

Experimental group

Description:

Dapagliflozin 10mg daily for 12 weeks.

Treatment:

Drug: Glibenclamide 5Mg Tablet

Drug: Dapagliflozin 10mg

Glibenclamide

Active Comparator group

Description:

Glibenclamide 5mg daily for 12 weeks.

Treatment:

Drug: Glibenclamide 5Mg Tablet

Drug: Dapagliflozin 10mg