Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089333
• Other study ID #: 2016004830
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Brazil	University of Campinas (UNICAMP)	Campinas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure	Change in Office Systolic Blood Pressure after 12 weeks of treatment	Baseline and 12 weeks
Secondary	Change in Ambulatory Systolic Blood Pressure	Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment	Baseline and 12 weeks
Secondary	Change in weight	Change in body weight	Baseline and 12 weeks
Secondary	Change in arterial stiffness	Change in arterial stiffness measured by Sphygmocor device	Baseline and 12 weeks
Secondary	Change in left ventricular hypertrophy	Change in left ventricular hypertrophy measured by Echocardiogram	Baseline and 12 weeks
Secondary	Change in microalbuminuria	Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio	Baseline and 12 weeks