Dapagliflozin on Blood Pressure Variability and Ambulatory Arterial Stiffness Index in Hypertension
Effect of Dapagliflozin on the Blood Pressure Variability and the Ambulatory Arterial Stiffness Index in Individuals With Stage I Hypertension Without Diabetes Mellitus
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 hypertension
Started Feb 2019
Typical duration for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedStudy Start
First participant enrolled
February 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedDecember 28, 2020
August 1, 2020
2.1 years
July 9, 2018
December 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Ambulatory arterial stiffness index
Arterial stiffness will be evaluated with ambulatory blood pressure monitoring
Baseline to Week 12
Secondary Outcomes (15)
Pulse Pressure of 24 h
Baseline to Week 12
Mean arterial pressure of 24 h, daytime and nigth-time
Baseline to Week 12
Heart rate of 24 h, daytime and nigth-time
Baseline to Week 12
Hypertensive load daytime and nigth-time
Baseline to Week 12
White coat hypertension
Baseline to Week 12
- +10 more secondary outcomes
Study Arms (2)
Dapagliflozin
EXPERIMENTALDapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Placebo
PLACEBO COMPARATORPlacebo capsules, one per day before breakfast during 12 weeks.
Interventions
10 mg, one per day before breakfast during 12 weeks.
One per day before breakfast during 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MANUEL GONZALEZ, PhD
University of Guadalajara
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor investigator titular C
Study Record Dates
First Submitted
July 9, 2018
First Posted
July 19, 2018
Study Start
February 14, 2019
Primary Completion
April 1, 2021
Study Completion
July 1, 2021
Last Updated
December 28, 2020
Record last verified: 2020-08