Dapagliflozin on Blood Pressure Variability and Ambulatory Arterial Stiffness Index in Hypertension
NCT ID: NCT03592667
Last Updated: 2020-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2019-02-14
2021-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin
10 mg, one per day before breakfast during 12 weeks.
Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo - Cap
One per day before breakfast during 12 weeks.
Interventions
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Dapagliflozin
10 mg, one per day before breakfast during 12 weeks.
Placebo - Cap
One per day before breakfast during 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
60 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Responsible Party
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Manuel González Ortiz
Professor investigator titular C
Principal Investigators
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MANUEL GONZALEZ, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Guadalajara
Locations
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Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico
Countries
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Central Contacts
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Facility Contacts
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MANUEL GONZALEZ, PhD
Role: primary
Other Identifiers
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DAPA on VBP-AASI Hypertension
Identifier Type: -
Identifier Source: org_study_id