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Short Term Effect of Empagliflozin in Hypertension

NCT ID: NCT04203914

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2017-09-30

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.

Conditions

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Hypertension

Keywords

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Hypertension Empagliflozin Left ventricular diastolic function Blood pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label trial with before and after design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Empagliflozin 25mg daily add-on therapy

Group Type EXPERIMENTAL

Empagliflozin Tablets

Intervention Type DRUG

Add-on 25mg once daily

Interventions

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Empagliflozin Tablets

Add-on 25mg once daily

Intervention Type DRUG

Other Intervention Names

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SGLT2-i

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yaounde Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sobngwi Eugene

Medical Advisor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Claude Mbanya, MD, PhD

Role: STUDY_CHAIR

University of Yaounde 1, Cameroon

Eugene Sobngwi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Yaounde 1, Cameroon

Locations

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National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Site Status

Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Site Status

Countries

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Cameroon

Other Identifiers

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CNO20168

Identifier Type: -

Identifier Source: org_study_id