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NCT Number: NCT04203914

Short Term Effect of Empagliflozin in Hypertension

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Obesity Centre, Yaounde Central Hospital, Yaoundé, Centre Region, Cameroon

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin Tablets

Drug

Add-on 25mg once daily

Other names: SGLT2-i

Primary outcomes

  1. Left ventricular diastolic function

    Time frame: 6 weeks

    Doppler ultrasound measured relaxation

Secondary outcomes

  1. Blood pressure

    Time frame: 6 weeks

    24-h ambulatory blood pressure

  2. HbA1c

    Time frame: 6 weeks

    Glycated haemoglobin

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Registry information

Official study title

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

Acronym: EMPHYT

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2019
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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