Short Term Effect of Empagliflozin in Hypertension

Hypertension Clinical Trial

— EMPHYT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203914
• Other study ID #: CNO20168
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: December 2019
• Source: Yaounde Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Empagliflozin Tablets
Add-on 25mg once daily

Locations

Country	Name	City	State
Cameroon	National Obesity Centre, Yaounde Central Hospital	Yaounde	Centre
Cameroon	Yaounde Central Hospital	Yaounde	Centre

Sponsors (1)

Lead Sponsor	Collaborator
Yaounde Central Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular diastolic function	Doppler ultrasound measured relaxation	6 weeks
Secondary	Blood pressure	24-h ambulatory blood pressure	6 weeks
Secondary	HbA1c	Glycated haemoglobin	6 weeks