Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects

NCT ID: NCT03089333

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dapagliflozin

Dapagliflozin 10mg daily for 12 weeks.

Group Type: EXPERIMENTAL

Dapagliflozin 10mg

Intervention Type: DRUG

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

Glibenclamide 5Mg Tablet

Intervention Type: DRUG

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

Glibenclamide

Glibenclamide 5mg daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Dapagliflozin 10mg

Intervention Type: DRUG

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

Glibenclamide 5Mg Tablet

Intervention Type: DRUG

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

Interventions

Dapagliflozin 10mg

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

Intervention Type: DRUG

Glibenclamide 5Mg Tablet

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

Intervention Type: DRUG

Other Intervention Names

FARXIGA®; Glibenclamide

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Modolo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Modolo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas

Locations

University of Campinas (UNICAMP)

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2016004830

Identifier Type: -

Identifier Source: org_study_id