HypertensionPhase 4EMPHYTNCT04203914
Short Term Effect of Empagliflozin in Hypertension
A Phase 4 study testing Empagliflozin Tablets in people with Hypertension, run by Yaounde Central Hospital at 2 sites in Cameroon.
Trial summary
The investigators assessed the 6-week effect of once daily 25mg SGLT2-i Empagliflozin on left ventricular diastolic function and blood pressure profile in non diabetic hypertensive patients Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Empagliflozin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCameroon
- Study dates
- 10 Jan 2017to 30 Sep 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 1 hypertension
- Grade 1 or 2 relaxation abnormalities (Doppler E/A ratio <1)
- Unchanged antihypertensive treatment for at least 12 weeks
Who cannot join
- Diabetes mellitus
- eGFR < 60 mL/min/1,73 m²
- Mitral stenosis
- Atrial fibrillation
- Alanine transferase above 2N
Trial locations and contacts
2 sites in 1 country.
Cameroon2 sites
National Obesity Centre, Yaounde Central Hospital
Yaoundé, Centre Region
Yaounde Central Hospital
Yaoundé, Centre Region
About this study
Official title: Short Term Effect of Empagliflozin on Left Ventricular Relaxation in Non Diabetic Hypertensive Patients
The investigators assessed the 6-week effect of once daily 25mg SGLT2-i Empagliflozin on left ventricular diastolic function and blood pressure profile in non diabetic hypertensive patients
Read the detailed description
Background: The rapid beneficial effects of Empagliflozin on cardiovascular mortality and hospitalizations rates for heart failure according to the Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial raise some question in the mechanism of myocardial action. The investigators conducted this study in a population of non-diabetic hypertensive patients in order to look for a short-term effect on left ventricular relaxation.
Methods: The investigators carried out a single arm non- randomized clinical trial and assigned patients to receive 25mg of empagliflozin once daily in additional therapy for six weeks at the National Center for Obesity and in the cardiology department of Yaounde Central Hospital in hypertensive patients with cardiac relaxation disorder. The objectives were to evaluate the left ventricular diastolic function and nycthemeral blood pressure profile.
- Conditions
- Hypertension
- Being tested
- Empagliflozin Tablets
- Keywords
- Hypertension, Empagliflozin, Left ventricular diastolic function, Blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin TabletsDrug
Also called SGLT2-i
Add-on 25mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Empagliflozin 25mg daily add-on therapy Receives: Drug: Empagliflozin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular diastolic function
Doppler ultrasound measured relaxation
Measured: 6 weeks
Secondary outcomes (2)
Blood pressure
24-h ambulatory blood pressure
Measured: 6 weeks
HbA1c
Glycated haemoglobin
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start10 Jan 2017
- Primary completion30 May 2017
- Study completion30 Sep 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label trial with before and after design
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaounde Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sobngwi Eugene, Yaounde Central Hospital
- Investigators
- Jean Claude Mbanya, MD, PhD, Study chair, University of Yaounde 1, CameroonEugene Sobngwi, MD, PhD, Principal investigator, University of Yaounde 1, Cameroon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203914
- Sponsor's protocol ID
- CNO20168
- Acronym
- EMPHYT
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Centrally available database available on request
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Empagliflozin on Left Ventricular Relaxation in Non Diabetic Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04203914
- Acronym / sponsor ID
- EMPHYT / CNO20168
- Conditions
- Hypertension
- Keywords
- Hypertension, Empagliflozin, Left ventricular diastolic function, Blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yaounde Central HospitalOther government
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 18 Dec 2019 (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 investigators assessed the 6-week effect of once daily 25mg SGLT2-i Empagliflozin on left ventricular diastolic function and blood pressure profile in non diabetic hypertensive patients
Detailed description
Background: The rapid beneficial effects of Empagliflozin on cardiovascular mortality and hospitalizations rates for heart failure according to the Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial raise some question in the mechanism of myocardial action. The investigators conducted this study in a population of non-diabetic hypertensive patients in order to look for a short-term effect on left ventricular relaxation.
Methods: The investigators carried out a single arm non- randomized clinical trial and assigned patients to receive 25mg of empagliflozin once daily in additional therapy for six weeks at the National Center for Obesity and in the cardiology department of Yaounde Central Hospital in hypertensive patients with cardiac relaxation disorder. The objectives were to evaluate the left ventricular diastolic function and nycthemeral blood pressure profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label trial with before and after design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Empagliflozin TabletsEmpagliflozin 25mg daily add-on therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Grade 1 hypertension
- Grade 1 or 2 relaxation abnormalities (Doppler E/A ratio <1)
- Unchanged antihypertensive treatment for at least 12 weeks
Key exclusion criteria (5 listed)
- Diabetes mellitus
- eGFR < 60 mL/min/1,73 m²
- Mitral stenosis
- Atrial fibrillation
- Alanine transferase above 2N
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 |
|---|---|---|
| Empagliflozin TabletsAlso: SGLT2-iAdd-on 25mg once daily | Drug | Intervention |
Primary outcome
Left ventricular diastolic function
Time frame: 6 weeks
Doppler ultrasound measured relaxation
2 secondary outcomes
Blood pressure
Time frame: 6 weeks
HbA1c
Time frame: 6 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 23 Dec 2019.
- Individual participant dataSharing planned: Yes. Centrally available database available on request
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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.
Jean Claude Mbanya, MD, PhD study chair
University of Yaounde 1, Cameroon
Eugene Sobngwi, MD, PhD principal investigator
University of Yaounde 1, Cameroon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin Tablets in people with Hypertension, run by Yaounde Central Hospital at 2 sites in Cameroon.
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 3 inclusion and 5 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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cameroon. 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?
Left ventricular diastolic function (time frame: 6 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 23 Dec 2019.