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Short Term Effect of Empagliflozin in Hypertension

Short Term Effect of Empagliflozin on Left Ventricular Relaxation in Non Diabetic Hypertensive Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04203914
Acronym
EMPHYT
Enrollment
15
Registered
2019-12-18
Start date
2017-01-10
Completion date
2017-09-30
Last updated
2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Empagliflozin, Left ventricular diastolic function, Blood pressure

Brief 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

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.

Interventions

Add-on 25mg once daily

Sponsors

Yaounde Central Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open label trial with before and after design

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Grade 1 hypertension * Grade 1 or 2 relaxation abnormalities (Doppler E/A ratio \<1) * Unchanged antihypertensive treatment for at least 12 weeks

Exclusion criteria

* Diabetes mellitus * eGFR \< 60 mL/min/1,73 m² * Mitral stenosis * Atrial fibrillation * Alanine transferase above 2N

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular diastolic function6 weeksDoppler ultrasound measured relaxation

Secondary

MeasureTime frameDescription
Blood pressure6 weeks24-h ambulatory blood pressure
HbA1c6 weeksGlycated haemoglobin

Countries

Cameroon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026