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

University of Guadalajara

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: Dapagliflozin; Drug: Placebo - Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT03592667

DAPA on VBP-AASI Hypertension

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Description:

Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.

Treatment:

Drug: Dapagliflozin

Placebo

Placebo Comparator group

Description:

Placebo capsules, one per day before breakfast during 12 weeks.

Treatment:

Drug: Placebo - Cap