Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects

Last updated: May 2, 2018
Sponsor: University of Campinas, Brazil
Overall Status: Completed

Phase

4

Condition

Proteinuria

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT03089333
2016004830
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • secondary Hypertension

  • pseudoresistance hypertension (poor medication adherence and white coat hypertension)

  • patients with symptomatic ischemic heart disease, impaired renal function, liverdisease and history of stroke, myocardial infarction and peripheral vascular diseases

  • pregnancy

  • smoking

  • autoimmune diseases

Study Design

Total Participants: 16
Study Start date:
July 01, 2016
Estimated Completion Date:
December 31, 2017

Study 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.

Connect with a study center

  • University of Campinas (UNICAMP)

    Campinas, São Paulo 13083970
    Brazil

    Site Not Available

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