Short Term Effect of Empagliflozin in Hypertension

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Empagliflozin Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label trial with before and after design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Empagliflozin 25mg daily add-on therapy | Drug: Empagliflozin Tablets<br>* Add-on 25mg once daily<br>* Other names: SGLT2-i;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular diastolic function | Doppler ultrasound measured relaxation | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | 24-h ambulatory blood pressure | 6 weeks | 
| HbA1c | Glycated haemoglobin | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Empagliflozin, Left ventricular diastolic function, Blood pressure