HypertensionPhase 4NCT03592667
Dapagliflozin on Blood Pressure Variability and Ambulatory Arterial Stiffness Index in Hypertension
A Phase 4 study testing Dapagliflozin in people with Hypertension, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 14 Feb 2019to Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Triglycerides ≥ 400 mg/dl
- Total cholesterol ≥ 240 mg/dl
- Worker per shift night
- Arrhythmia
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340
MANUEL GONZALEZ, PhD, +52-10-58-52-00 ext. 34212, uiec@prodigy.net.mx
About this study
Official title: Effect of Dapagliflozin on the Blood Pressure Variability and the Ambulatory Arterial Stiffness Index in Individuals With Stage I Hypertension Without Diabetes Mellitus
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.
Read more
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.
Read the detailed 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.
- Conditions
- Hypertension
- Being tested
- Dapagliflozin, Placebo - Cap
- Keywords
- Stage I Hypertension, Without type 2 diabetes mellitus, Variability of blood pressure, Ambulatory arterial stiffness index, Dapagliflozin, ABPM
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
10 mg, one per day before breakfast during 12 weeks.
Placebo - CapDrug
Also called Calcined magnesium
One per day before breakfast during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Receives: Drug: Dapagliflozin |
| Placebo | Placebo comparator | Placebo capsules, one per day before breakfast during 12 weeks. Receives: Drug: Placebo - Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Week 12
Ambulatory arterial stiffness index
Arterial stiffness will be evaluated with ambulatory blood pressure monitoring
Measured: Baseline to Week 12
Secondary outcomes (15)
Pulse Pressure of 24 h
Will be evaluated with ambulatory blood pressure monitoring, systolic BP minus diastolic BP.
Measured: Baseline to Week 12
Mean arterial pressure of 24 h, daytime and nigth-time
Will be evaluated with ambulatory blood pressure monitoring, systolic BP minus diastolic BP/3, plus diastolic BP.
Measured: Baseline to Week 12
Heart rate of 24 h, daytime and nigth-time
Will be evaluated with ambulatory blood pressure monitoring.
Measured: Baseline to Week 12
Hypertensive load daytime and nigth-time
Will be evaluated with ambulatory blood pressure monitoring.
Measured: Baseline to Week 12
White coat hypertension
will be evaluated with ambulatory blood pressure monitoring
Measured: Baseline to Week 12
Fasting glucose levels
The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12.
Measured: Baseline to Week 12
Total cholesterol
Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
Measured: Baseline to Week 12
Triglycerides levels
Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Measured: Baseline to Week 12
High density lipoprotein (c-HDL) levels
c-HDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Measured: Baseline to Week 12
Creatinine levels
Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Measured: Baseline to Week 12
Uric acid levels
Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Measured: Baseline to Week 12
Body Weight
The body weight will be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12
Measured: Baseline, week 4, week 8 and week 12
Body Mass Index
Body Mas Index will be calculated at baseline, week 4, week 8 and week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12
Measured: Baseline, week 4, week 8 and week 12
Waist circumference
Waist circumference will be evaluated with the method proposed by ISAK.
Measured: Baseline, week 4, week 8 and week 12
Glomerular filtration rate
Glomerular filtration rate will be calculated at baseline and week 12 with the Cockcroft-Gault formula and the entered values reflect the Glomerular filtration rate at week 12
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start14 Feb 2019
- Primary completionApr 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel González Ortiz, University of Guadalajara
- Investigators
- MANUEL GONZALEZ, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592667
- Sponsor's protocol ID
- DAPA on VBP-AASI Hypertension
- Status last verified
- Aug 2020
- First submitted
- 9 Jul 2018
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin on the Blood Pressure Variability and the Ambulatory Arterial Stiffness Index in Individuals With Stage I Hypertension Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03592667
- Acronym / sponsor ID
- DAPA on VBP-AASI Hypertension
- Conditions
- Hypertension
- Keywords
- Stage I Hypertension, Without type 2 diabetes mellitus, Variability of blood pressure, Ambulatory arterial stiffness index, Dapagliflozin, ABPM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. |
| Placebo | Placebo comparator | Drug: Placebo - CapPlacebo capsules, one per day before breakfast during 12 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinAlso: Forxiga10 mg, one per day before breakfast during 12 weeks. | Drug | Dapagliflozin |
| Placebo - CapAlso: Calcined magnesiumOne per day before breakfast during 12 weeks. | Drug | Placebo |
Primary outcome
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
Blood pressure variability will be evaluated with ambulatory blood pressure monitoring
Ambulatory arterial stiffness index
Time frame: Baseline to Week 12
Arterial stiffness will be evaluated with ambulatory blood pressure monitoring
15 secondary outcomes
Pulse Pressure of 24 h
Time frame: Baseline to Week 12
Mean arterial pressure of 24 h, daytime and nigth-time
Time frame: Baseline to Week 12
Heart rate of 24 h, daytime and nigth-time
Time frame: Baseline to Week 12
Hypertensive load daytime and nigth-time
Time frame: Baseline to Week 12
White coat hypertension
Time frame: Baseline to Week 12
Fasting glucose levels
Time frame: Baseline to Week 12
Total cholesterol
Time frame: Baseline to Week 12
Triglycerides levels
Time frame: Baseline to Week 12
High density lipoprotein (c-HDL) levels
Time frame: Baseline to Week 12
Creatinine levels
Time frame: Baseline to Week 12
Uric acid levels
Time frame: Baseline to Week 12
Body Weight
Time frame: Baseline, week 4, week 8 and week 12
Body Mass Index
Time frame: Baseline, week 4, week 8 and week 12
Waist circumference
Time frame: Baseline, week 4, week 8 and week 12
Glomerular filtration rate
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MANUEL GONZALEZ, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Hypertension, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MANUEL GONZALEZ, PhD (+52-10-58-52-00 ext. 34212, uiec@prodigy.net.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.