Short Term Effect of Empagliflozin in Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Empagliflozin Tablets

• Registration Number: NCT04203914
• Lead Sponsor: Yaounde Central Hospital

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.

Study Timeline

• Study Start: 2017-01-10
• Primary Completion: 2017-05-30
• Study Completion: 2017-09-30
• Status Verified: 2019-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Empagliflozin Tablets	Empagliflozin 25mg daily add-on therapy

Primary Outcome Measures

Name	Time	Method
Left ventricular diastolic function	6 weeks	Doppler ultrasound measured relaxation

Secondary Outcome Measures

Name	Time	Method
HbA1c	6 weeks	Glycated haemoglobin
Blood pressure	6 weeks	24-h ambulatory blood pressure

Trial Locations

Locations (2)

National Obesity Centre, Yaounde Central Hospital; 🇨🇲 Yaounde, Centre, Cameroon

Yaounde Central Hospital; 🇨🇲 Yaounde, Centre, Cameroon