Clinical trial NCT03089333: Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects
Official title: Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile in Resistant Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Diabetes Mellitus, Type 2
Blood Pressure
Obesity
Cardiac Hypertrophy
Microalbuminuria
Vascular Stiffness
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2017-03-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two-way crossover design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Ambulatory Systolic Blood Pressure
timeFrame: Baseline and 12 weeks
measure: Change in weight
timeFrame: Baseline and 12 weeks
measure: Change in arterial stiffness
timeFrame: Baseline and 12 weeks
measure: Change in left ventricular hypertrophy
timeFrame: Baseline and 12 weeks
measure: Change in microalbuminuria
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas (UNICAMP)
state: São Paulo
Study officials:
affiliation: University of Campinas
name: Rodrigo Modolo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: