Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects
2018年5月2日 更新者:Rodrigo Modolo、University of Campinas, Brazil
Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile 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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
16
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
São Paulo
-
Campinas、São Paulo、巴西、13083970
- University of Campinas (UNICAMP)
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Dapagliflozin
Dapagliflozin 10mg daily for 12 weeks.
|
Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
其他名称:
Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
其他名称:
|
|
有源比较器:Glibenclamide
Glibenclamide 5mg daily for 12 weeks.
|
Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
其他名称:
Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Systolic Blood Pressure
大体时间:Baseline and 12 weeks
|
Change in Office Systolic Blood Pressure after 12 weeks of treatment
|
Baseline and 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Ambulatory Systolic Blood Pressure
大体时间:Baseline and 12 weeks
|
Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment
|
Baseline and 12 weeks
|
|
Change in weight
大体时间:Baseline and 12 weeks
|
Change in body weight
|
Baseline and 12 weeks
|
|
Change in arterial stiffness
大体时间:Baseline and 12 weeks
|
Change in arterial stiffness measured by Sphygmocor device
|
Baseline and 12 weeks
|
|
Change in left ventricular hypertrophy
大体时间:Baseline and 12 weeks
|
Change in left ventricular hypertrophy measured by Echocardiogram
|
Baseline and 12 weeks
|
|
Change in microalbuminuria
大体时间:Baseline and 12 weeks
|
Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio
|
Baseline and 12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Rodrigo Modolo, MD, PhD、University of Campinas
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月1日
初级完成 (实际的)
2017年10月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2017年3月20日
首先提交符合 QC 标准的
2017年3月20日
首次发布 (实际的)
2017年3月24日
研究记录更新
最后更新发布 (实际的)
2018年5月8日
上次提交的符合 QC 标准的更新
2018年5月2日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.