Hypertension Clinical Trial
Official title:
Effect of Dapagliflozin on the Blood Pressure Variability and the Ambulatory Arterial Stiffness Index in Individuals With Stage I Hypertension Without Diabetes Mellitus
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
University of Guadalajara |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Indices of blood pressure: 24 h, daytime and night-time SD and CV, 24 h weighted SD, day-to-nigth BP changes and ARV | Blood pressure variability will be evaluated with ambulatory blood pressure monitoring | Baseline to Week 12 | |
Primary | Ambulatory arterial stiffness index | Arterial stiffness will be evaluated with ambulatory blood pressure monitoring | Baseline to Week 12 | |
Secondary | Pulse Pressure of 24 h | Will be evaluated with ambulatory blood pressure monitoring, systolic BP minus diastolic BP. | Baseline to Week 12 | |
Secondary | Mean arterial pressure of 24 h, daytime and nigth-time | Will be evaluated with ambulatory blood pressure monitoring, systolic BP minus diastolic BP/3, plus diastolic BP. | Baseline to Week 12 | |
Secondary | Heart rate of 24 h, daytime and nigth-time | Will be evaluated with ambulatory blood pressure monitoring. | Baseline to Week 12 | |
Secondary | Hypertensive load daytime and nigth-time | Will be evaluated with ambulatory blood pressure monitoring. | Baseline to Week 12 | |
Secondary | White coat hypertension | will be evaluated with ambulatory blood pressure monitoring | Baseline to Week 12 | |
Secondary | Fasting glucose levels | 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. | Baseline to Week 12 | |
Secondary | Total cholesterol | 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 | Baseline to Week 12 | |
Secondary | Triglycerides levels | 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 | Baseline to Week 12 | |
Secondary | High density lipoprotein (c-HDL) levels | 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 | Baseline to Week 12 | |
Secondary | Creatinine levels | Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques | Baseline to Week 12 | |
Secondary | Uric acid levels | Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques | Baseline to Week 12 | |
Secondary | Body Weight | 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 | Baseline, week 4, week 8 and week 12 | |
Secondary | Body Mass Index | 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 | Baseline, week 4, week 8 and week 12 | |
Secondary | Waist circumference | Waist circumference will be evaluated with the method proposed by ISAK. | Baseline, week 4, week 8 and week 12 | |
Secondary | Glomerular filtration rate | 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 | Baseline to Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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