Dapagliflozin on Blood Pressure Variability and Ambulatory Arterial Stiffness Index in Hypertension

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Guadalajara
• Treatments: Dapagliflozin

Criteria

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