Short Term Effect of Empagliflozin in Hypertension (EMPHYT)

Yaounde Central Hospital

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Empagliflozin Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04203914

CNO20168

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intervention

Experimental group

Description:

Empagliflozin 25mg daily add-on therapy

Treatment:

Drug: Empagliflozin Tablets