Short Term Effect of Empagliflozin in Hypertension | NCT04203914

Studies
Short Term Effect of Empagliflozin in Hypertension

NCT04203914

Sponsor

Yaounde Central Hospital

Status

Completed

Last Update Posted

Dec 23, 2019Actual

Enrollment

15Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Empagliflozin Tablets

Countries

Cameroon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2017Actual

Primary Completion Date

May 30, 2017Actual

Completion Date

Sep 30, 2017Actual

First Submitted Date

Dec 17, 2019

First Submission Date that Met QC Criteria

Dec 17, 2019

First Posted Date

Dec 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2019

Last Update Posted Date

Dec 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Empagliflozin 25mg daily add-on therapy	Drug: Empagliflozin Tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin Tablets	Drug	Add-on 25mg once daily	Intervention	SGLT2-i

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Claude Mbanya, MD, PhD	University of Yaounde 1, Cameroon	Study Chair
Eugene Sobngwi, MD, PhD	University of Yaounde 1, Cameroon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Obesity Centre, Yaounde Central Hospital		Yaoundé	Centre Region		Cameroon
Yaounde Central Hospital

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Centrally available database available on request

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

December 2019 for 5 years

Access Criteria

Requirements of Cameroon Ethics authorities

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C570240	empagliflozin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided