NCT04203914

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

5 months

First QC Date

December 17, 2019

Last Update Submit

December 18, 2019

Conditions

Hypertension

Keywords

HypertensionEmpagliflozinLeft ventricular diastolic functionBlood pressure

Outcome Measures

Primary Outcomes (1)

  • Left ventricular diastolic function

    Doppler ultrasound measured relaxation

    6 weeks

Secondary Outcomes (2)

  • Blood pressure

    6 weeks

  • HbA1c

    6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Empagliflozin 25mg daily add-on therapy

Drug: Empagliflozin Tablets

Interventions

Empagliflozin TabletsDRUG

Add-on 25mg once daily

Also known as: SGLT2-i
Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Grade 1 hypertension
  • Grade 1 or 2 relaxation abnormalities (Doppler E/A ratio \<1)
  • Unchanged antihypertensive treatment for at least 12 weeks

You may not qualify if:

  • Diabetes mellitus
  • eGFR \< 60 mL/min/1,73 m²
  • Mitral stenosis
  • Atrial fibrillation
  • Alanine transferase above 2N

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Obesity Centre, Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Location

Yaounde Central Hospital

Yaoundé, Centre Region, Cameroon

Location

MeSH Terms

Conditions

Hypertension

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Jean Claude Mbanya, MD, PhD

    University of Yaounde 1, Cameroon

    STUDY CHAIR

  • Eugene Sobngwi, MD, PhD

    University of Yaounde 1, Cameroon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label trial with before and after design
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Advisor

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 18, 2019

Study Start

January 10, 2017

Primary Completion

May 30, 2017

Study Completion

September 30, 2017

Last Updated

December 23, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

Centrally available database available on request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
December 2019 for 5 years
Access Criteria
Requirements of Cameroon Ethics authorities

Locations

CA(2)