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NCT Number: NCT03089333

Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects

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.

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Key information

Conditions

Hypertension Blood Pressure Body Weight Cardiac Hypertrophy Cardiomegaly Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypertrophy Metabolic Diseases Microalbuminuria Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Vascular Stiffness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Campinas (UNICAMP)

Campinas, São Paulo, 13083970, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin 10mg

Drug

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

Other names: FARXIGA®

Glibenclamide 5Mg Tablet

Drug

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

Other names: Glibenclamide

Primary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: Baseline and 12 weeks

    Change in Office Systolic Blood Pressure after 12 weeks of treatment

Secondary outcomes

  1. Change in Ambulatory Systolic Blood Pressure

    Time frame: Baseline and 12 weeks

    Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment

  2. Change in weight

    Time frame: Baseline and 12 weeks

    Change in body weight

  3. Change in arterial stiffness

    Time frame: Baseline and 12 weeks

    Change in arterial stiffness measured by Sphygmocor device

  4. Change in left ventricular hypertrophy

    Time frame: Baseline and 12 weeks

    Change in left ventricular hypertrophy measured by Echocardiogram

  5. Change in microalbuminuria

    Time frame: Baseline and 12 weeks

    Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2017
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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