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临床试验/NCT03089333
NCT03089333已完成4 期

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

University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Change in Systolic Blood Pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • autoimmune diseases

研究组 & 干预措施

Dapagliflozin

Experimental

Dapagliflozin 10mg daily for 12 weeks.

干预措施: Dapagliflozin 10mg (Drug)

Dapagliflozin

Experimental

Dapagliflozin 10mg daily for 12 weeks.

干预措施: Glibenclamide 5Mg Tablet (Drug)

Glibenclamide

Active Comparator

Glibenclamide 5mg daily for 12 weeks.

干预措施: Dapagliflozin 10mg (Drug)

Glibenclamide

Active Comparator

Glibenclamide 5mg daily for 12 weeks.

干预措施: Glibenclamide 5Mg Tablet (Drug)

结局指标

主要结局

Change in Systolic Blood Pressure

时间窗: Baseline and 12 weeks

Change in Office Systolic Blood Pressure after 12 weeks of treatment

次要结局

  • Change in arterial stiffness(Baseline and 12 weeks)
  • Change in left ventricular hypertrophy(Baseline and 12 weeks)
  • Change in Ambulatory Systolic Blood Pressure(Baseline and 12 weeks)
  • Change in weight(Baseline and 12 weeks)
  • Change in microalbuminuria(Baseline and 12 weeks)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Modolo

Principal Investigator

University of Campinas, Brazil

研究点 (1)

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