Effect of Dapagliflozin on the Blood Pressure Variability and the Ambulatory Arterial Stiffness Index in Individuals With Stage I Hypertension Without Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Indices of blood pressure: 24 h, daytime and night-time SD and CV, 24 h weighted SD, day-to-nigth BP changes and ARV
研究概览
简要总结
The prevalence of arterial hypertension has remained the same in the last 5 years, however, almost 50% of the population continues without an adequate adjustment according to the National Health Survey of the Midway 2016.
It has been shown that the variability of blood pressure (VBP) during 24 h and visit-visit is associated with cardiovascular diseases (CVD) over the effect of blood pressure (BP) itself. On the other hand, arterial stiffness is well known as an independent factor of CVD risk and for its evaluation the ambulatory arterial stiffness index (AASI) has been proposed. AASI and the VPA obtained through an evaluation by ambulatory BP monitoring (ABPM) individual of 24 h.
Dapagliflozin is an inhibitor of the sodium-glucose cotransporter type 2 (iSGLT2) for the treatment of diabetes mellitus type 2 (DM2) that promotes natriuresis and osmotic diuresis, which produces a decrease in plasma volume and a decrease in BP.
The aim of ths study is to evaluate the effect of dapagliflozin on VBP and AASI in individuals with stage I hypertension whitout DM2.
The investigators hypothesis is that the administration of dapagliflozin decreases the VBP and AASI in individuals with stage I hypertension whitout DM2.
详细描述
A randomized, double-blind, placebo-controlled clinical trial in 20 patients with a diagnosis of stage I hypertension without DM2.
They will be assigned randomly two groups of 10 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.
There will be calculated indices of VBP: 24 h, daytime and night-time standard deviation (SD), coefficient of variation (CV), 24 h weighted SD, Day-to-nigth BP changes and average real variability (AVR). On the other hand, AASI will be calculated with a linear regression.
This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2 o exact fisher test, will be used for differences inter-group. Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed
- •Patients both sexes, age between 30 and 60 years
- •Diagnosis of stage I hypertension according ACC/AHA (American college of cardiology/American heart association) blood pressure between 130-139/ 80-89 mmHg.
- •Fasting plasma glucose < 100 mg/dl
- •BMI >35 kg/m2
- •Glomerular filtration rate > 60ml/min/1.73m2
排除标准
- •Women with confirmed or suspected pregnancy
- •Women under lactation and/or puerperium
- •Hypersensibility to ingredients of intervention
- •Physical impossibility for taking pills
- •Known uncontrolled renal, hepatic, heart, thyroid or cardiovascular diseased
- •Previous treatment for hypertension or depression
- •Triglycerides ≥ 400 mg/dl
- •Total cholesterol ≥ 240 mg/dl
- •Worker per shift night
- •Arrhythmia
研究组 & 干预措施
Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
干预措施: Dapagliflozin (Drug)
Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
干预措施: Placebo - Cap (Drug)
结局指标
主要结局
Indices of blood pressure: 24 h, daytime and night-time SD and CV, 24 h weighted SD, day-to-nigth BP changes and ARV
时间窗: Baseline to Week 12
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring
Ambulatory arterial stiffness index
时间窗: Baseline to Week 12
Arterial stiffness will be evaluated with ambulatory blood pressure monitoring
次要结局
- Pulse Pressure of 24 h(Baseline to Week 12)
- Mean arterial pressure of 24 h, daytime and nigth-time(Baseline to Week 12)
- Heart rate of 24 h, daytime and nigth-time(Baseline to Week 12)
- Hypertensive load daytime and nigth-time(Baseline to Week 12)
- White coat hypertension(Baseline to Week 12)
- Fasting glucose levels(Baseline to Week 12)
- Total cholesterol(Baseline to Week 12)
- Triglycerides levels(Baseline to Week 12)
- High density lipoprotein (c-HDL) levels(Baseline to Week 12)
- Creatinine levels(Baseline to Week 12)
- Uric acid levels(Baseline to Week 12)
- Body Weight(Baseline, week 4, week 8 and week 12)
- Body Mass Index(Baseline, week 4, week 8 and week 12)
- Waist circumference(Baseline, week 4, week 8 and week 12)
- Glomerular filtration rate(Baseline to Week 12)
研究者
Manuel González Ortiz
Professor investigator titular C
University of Guadalajara