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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03089333
Other study ID # 2016004830
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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