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

Sponsor
University of Guadalajara
Study ID
NCT03592667
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg, one per day before breakfast during 12 weeks.
  • Placebo - Cap — DRUG
    One per day before breakfast during 12 weeks.

Study Details

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.

Key Dates

Start date
Feb 14, 2019
Status verified
Aug 2020
Primary completion
Apr 30, 2021
Completion
Jul 31, 2021

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
  • Placebo Comparator: Placebo
    Placebo capsules, one per day before breakfast during 12 weeks.

Primary Outcome Measure

Indices of blood pressure: 24 h, daytime and night-time SD and CV, 24 h weighted SD, day-to-nigth BP changes and ARV [ Time Frame: Baseline to Week 12 ]

Central Contacts

Related Studies