Hypertension
Conditions
Keywords
Stage I Hypertension, Without type 2 diabetes mellitus, Variability of blood pressure, Ambulatory arterial stiffness index, Dapagliflozin, ABPM
Brief summary
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.
Detailed description
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.
Interventions
DRUGDapagliflozin
10 mg, one per day before breakfast during 12 weeks.
DRUGPlacebo - Cap
One per day before breakfast during 12 weeks.
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Indices of blood pressure: 24 h, daytime and night-time SD and CV, 24 h weighted SD, day-to-nigth BP changes and ARV | Baseline to Week 12 | Blood pressure variability will be evaluated with ambulatory blood pressure monitoring |
| Ambulatory arterial stiffness index | Baseline to Week 12 | Arterial stiffness will be evaluated with ambulatory blood pressure monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate of 24 h, daytime and nigth-time | Baseline to Week 12 | Will be evaluated with ambulatory blood pressure monitoring. |
| Hypertensive load daytime and nigth-time | Baseline to Week 12 | Will be evaluated with ambulatory blood pressure monitoring. |
| White coat hypertension | Baseline to Week 12 | will be evaluated with ambulatory blood pressure monitoring |
| Fasting glucose levels | Baseline to Week 12 | The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12. |
| Total cholesterol | Baseline to Week 12 | Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12 |
| Triglycerides levels | Baseline to Week 12 | Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12 |
| Pulse Pressure of 24 h | Baseline to Week 12 | Will be evaluated with ambulatory blood pressure monitoring, systolic BP minus diastolic BP. |
| Creatinine levels | Baseline to Week 12 | Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques |
| Uric acid levels | Baseline to Week 12 | Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques |
| Body Weight | Baseline, week 4, week 8 and week 12 | The body weight will be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12 |
| Body Mass Index | Baseline, week 4, week 8 and week 12 | Body Mas Index will be calculated at baseline, week 4, week 8 and week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12 |
| Waist circumference | Baseline, week 4, week 8 and week 12 | Waist circumference will be evaluated with the method proposed by ISAK. |
| Glomerular filtration rate | Baseline to Week 12 | Glomerular filtration rate will be calculated at baseline and week 12 with the Cockcroft-Gault formula and the entered values reflect the Glomerular filtration rate at week 12 |
| High density lipoprotein (c-HDL) levels | Baseline to Week 12 | c-HDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12 |
| Mean arterial pressure of 24 h, daytime and nigth-time | Baseline to Week 12 | Will be evaluated with ambulatory blood pressure monitoring, systolic BP minus diastolic BP/3, plus diastolic BP. |
Countries
Mexico
Contacts
Primary ContactMANUEL GONZALEZ, PhD
Backup ContactLIZET YADIRA ROSALES, PhD
Outcome results
None listed