HypertensionPhase 4NCT03089333
Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects
A Phase 4 study testing Dapagliflozin 10mg and Glibenclamide 5Mg Tablet in people with Hypertension and Diabetes Mellitus, Type 2, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
New strategies trying to achieve blood pressure control and consequently reduce cardiovascular risk in resistant hypertensive subjects are promising. In this context, the SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a potential drug in order to impact on blood pressure… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2, Blood Pressure
- What is being tested?
- Dapagliflozin 10mg and Glibenclamide 5Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Dec 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resistant hypertension and type 2 diabetes diagnoses after a 6-month follow-up
- Use of metformin therapy
- Therapy adherence
- Agree to participate in the research protocol and sign the informed consent form
Who cannot join
- secondary Hypertension
- pseudoresistance hypertension (poor medication adherence and white coat hypertension)
- patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases
- pregnancy
- smoking
- autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile in Resistant Hypertensive Subjects
New strategies trying to achieve blood pressure control and consequently reduce cardiovascular risk in resistant hypertensive subjects are promising. In this context, the SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a potential drug in order to impact on blood pressure levels, as well as target organ damage and adiposity in this high-risk population.
Read the detailed description
Objective: The investigators aim to assess whether the intervention with the SGLT2 inhibitor -dapaglifozin - reduces PA levels, target organ damage, fat profile and change the adipokines levels in patients with resistant hypertension with DM2. Methods and design: This crossover randomized, double-blind, interventional study controlled by standard therapy will include 20 patients with resistant hypertension and type 2 diabetes, followed in Outpatient Clinic specialized in Resistant Hypertension at clinical Hospital-UNICAMP. They will be randomly assigned into two groups (1) initially treated with dapagliflozin in combination with their usual antihypertensive therapy and metformin, at 12 weeks (n = 10) or group (2) Control initially treated with glibenclamide at a dose of 5mg daily in combination with antihypertensive therapy usual and metformin, at 12 weeks (n = 10). Office ambulatory and home BP measurements; anthropometric measurements, determination of vascular stiffness by pulse wave velocity, echocardiogram, body bioimpedance, enzyme immunoassays for the determination of adipokines, and lab tests to evaluate biochemical parameters will be performed pre- and after the use of both treatments. Glycemic parameters, and weight will be assessed every 4 weeks. Results and conclusion: The use of SGLT2 inhibitor in these patients may provide new strategies for treatment of patients with resistant hypertension.
- Conditions
- Hypertension, Diabetes Mellitus, Type 2, Blood Pressure, Obesity, Cardiac Hypertrophy, Microalbuminuria
- Being tested
- Dapagliflozin 10mg, Glibenclamide 5Mg Tablet
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Obesity, Cardiomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mgDrug
Also called FARXIGA®
Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
Glibenclamide 5Mg TabletDrug
Also called Glibenclamide
Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10mg daily for 12 weeks. Receives: Drug: Dapagliflozin 10mg; Drug: Glibenclamide 5Mg Tablet |
| Glibenclamide | Active comparator | Glibenclamide 5mg daily for 12 weeks. Receives: Drug: Dapagliflozin 10mg; Drug: Glibenclamide 5Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure
Change in Office Systolic Blood Pressure after 12 weeks of treatment
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Change in Ambulatory Systolic Blood Pressure
Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment
Measured: Baseline and 12 weeks
Change in weight
Change in body weight
Measured: Baseline and 12 weeks
Change in arterial stiffness
Change in arterial stiffness measured by Sphygmocor device
Measured: Baseline and 12 weeks
Change in left ventricular hypertrophy
Change in left ventricular hypertrophy measured by Echocardiogram
Measured: Baseline and 12 weeks
Change in microalbuminuria
Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startJul 2016
- Primary completionOct 2017
- Study completionDec 2017
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
- Crossover
- Model description
- Two-way crossover design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Rodrigo Modolo, University of Campinas, Brazil
- Investigators
- Rodrigo Modolo, MD, PhD, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089333
- Sponsor's protocol ID
- 2016004830
- Status last verified
- May 2018
- First submitted
- 20 Mar 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dapagliflozin, an SGLT2 Inhibitor, on Hemodynamic Parameters, Target Organ Damage and Obesity Profile in Resistant Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT03089333
- Acronym / sponsor ID
- 2016004830
- Conditions
- Hypertension, Diabetes Mellitus, Type 2, Blood Pressure, Obesity, Cardiac Hypertrophy, Microalbuminuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Mar 2017 (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.
New strategies trying to achieve blood pressure control and consequently reduce cardiovascular risk in resistant hypertensive subjects are promising. In this context, the SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a potential drug in order to impact on blood pressure levels, as well as target organ damage and adiposity in this high-risk population.
Detailed description
Objective: The investigators aim to assess whether the intervention with the SGLT2 inhibitor -dapaglifozin - reduces PA levels, target organ damage, fat profile and change the adipokines levels in patients with resistant hypertension with DM2. Methods and design: This crossover randomized, double-blind, interventional study controlled by standard therapy will include 20 patients with resistant hypertension and type 2 diabetes, followed in Outpatient Clinic specialized in Resistant Hypertension at clinical Hospital-UNICAMP. They will be randomly assigned into two groups (1) initially treated with dapagliflozin in combination with their usual antihypertensive therapy and metformin, at 12 weeks (n = 10) or group (2) Control initially treated with glibenclamide at a dose of 5mg daily in combination with antihypertensive therapy usual and metformin, at 12 weeks (n = 10). Office ambulatory and home BP measurements; anthropometric measurements, determination of vascular stiffness by pulse wave velocity, echocardiogram, body bioimpedance, enzyme immunoassays for the determination of adipokines, and lab tests to evaluate biochemical parameters will be performed pre- and after the use of both treatments. Glycemic parameters, and weight will be assessed every 4 weeks. Results and conclusion: The use of SGLT2 inhibitor in these patients may provide new strategies for treatment of patients with resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two-way crossover design
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10mg, Drug: Glibenclamide 5Mg TabletDapagliflozin 10mg daily for 12 weeks. |
| Glibenclamide | Active comparator | Drug: Dapagliflozin 10mg, Drug: Glibenclamide 5Mg TabletGlibenclamide 5mg daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Resistant hypertension and type 2 diabetes diagnoses after a 6-month follow-up
- Use of metformin therapy
- Therapy adherence
- Agree to participate in the research protocol and sign the informed consent form
Key exclusion criteria (6 listed)
- secondary Hypertension
- pseudoresistance hypertension (poor medication adherence and white coat hypertension)
- patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases
- pregnancy
- smoking
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 |
|---|---|---|
| Dapagliflozin 10mgAlso: FARXIGA®Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks | Drug | Dapagliflozin, Glibenclamide |
| Glibenclamide 5Mg TabletAlso: GlibenclamideGlibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks | Drug | Dapagliflozin, Glibenclamide |
Primary outcome
Change in Systolic Blood Pressure
Time frame: Baseline and 12 weeks
Change in Office Systolic Blood Pressure after 12 weeks of treatment
5 secondary outcomes
Change in Ambulatory Systolic Blood Pressure
Time frame: Baseline and 12 weeks
Change in weight
Time frame: Baseline and 12 weeks
Change in arterial stiffness
Time frame: Baseline and 12 weeks
Change in left ventricular hypertrophy
Time frame: Baseline and 12 weeks
Change in microalbuminuria
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Rodrigo Modolo, MD, PhD principal investigator
University of Campinas
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 10mg and Glibenclamide 5Mg Tablet in people with Hypertension and Diabetes Mellitus, Type 2, run by University of Campinas, Brazil at 1 site in Brazil.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 May 2018. 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 Brazil. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (time frame: Baseline and 12 weeks). 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 8 May 2018.