NCT03089333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

March 20, 2017

Last Update Submit

May 2, 2018

Conditions

HypertensionDiabetes Mellitus, Type 2Blood PressureObesityCardiac HypertrophyMicroalbuminuriaVascular Stiffness

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic Blood Pressure

    Change in Office Systolic Blood Pressure after 12 weeks of treatment

    Baseline and 12 weeks

Secondary Outcomes (5)

  • Change in Ambulatory Systolic Blood Pressure

    Baseline and 12 weeks

  • Change in weight

    Baseline and 12 weeks

  • Change in arterial stiffness

    Baseline and 12 weeks

  • Change in left ventricular hypertrophy

    Baseline and 12 weeks

  • Change in microalbuminuria

    Baseline and 12 weeks

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10mg daily for 12 weeks.

Drug: Dapagliflozin 10mgDrug: Glibenclamide 5Mg Tablet

Glibenclamide

ACTIVE COMPARATOR

Glibenclamide 5mg daily for 12 weeks.

Drug: Dapagliflozin 10mgDrug: Glibenclamide 5Mg Tablet

Interventions

Dapagliflozin 10mgDRUG

Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks

Also known as: FARXIGA®
DapagliflozinGlibenclamide
Glibenclamide 5Mg TabletDRUG

Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks

Also known as: Glibenclamide
DapagliflozinGlibenclamide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas (UNICAMP)

Campinas, São Paulo, 13083970, Brazil

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2ObesityCardiomegaly

Interventions

dapagliflozinGlyburideTablets

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesHypertrophyPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Rodrigo Modolo, MD, PhD

    University of Campinas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Two-way crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

July 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

BR(1)