Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects

May 2, 2018 updated by: Rodrigo Modolo, University of Campinas, Brazil

Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile in Resistant Hypertensive Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083970
        • University of Campinas (UNICAMP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin
Dapagliflozin 10mg daily for 12 weeks.
Drug: Dapagliflozin 10mg
Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
Other Names:
  • FARXIGA®
Drug: Glibenclamide 5Mg Tablet
Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
Other Names:
  • Glibenclamide
Active Comparator: Glibenclamide
Glibenclamide 5mg daily for 12 weeks.
Drug: Dapagliflozin 10mg
Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
Other Names:
  • FARXIGA®
Drug: Glibenclamide 5Mg Tablet
Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
Other Names:
  • Glibenclamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: Baseline and 12 weeks
Change in Office Systolic Blood Pressure after 12 weeks of treatment
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ambulatory Systolic Blood Pressure
Time Frame: Baseline and 12 weeks
Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment
Baseline and 12 weeks
Change in weight
Time Frame: Baseline and 12 weeks
Change in body weight
Baseline and 12 weeks
Change in arterial stiffness
Time Frame: Baseline and 12 weeks
Change in arterial stiffness measured by Sphygmocor device
Baseline and 12 weeks
Change in left ventricular hypertrophy
Time Frame: Baseline and 12 weeks
Change in left ventricular hypertrophy measured by Echocardiogram
Baseline and 12 weeks
Change in microalbuminuria
Time Frame: Baseline and 12 weeks
Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Rodrigo Modolo, MD, PhD, University of Campinas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016004830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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