Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects

Sponsor
University of Campinas, Brazil
Study ID
NCT03089333
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg — DRUG
    Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
  • Glibenclamide 5Mg Tablet — DRUG
    Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks

Study Details

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.

Key Dates

Start date
Jul 31, 2016
Status verified
May 2018
Primary completion
Oct 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10mg daily for 12 weeks.
  • Active Comparator: Glibenclamide
    Glibenclamide 5mg daily for 12 weeks.

Primary Outcome Measure

Change in Systolic Blood Pressure [ Time Frame: Baseline and 12 weeks ]

Related Studies