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临床试验/NCT04203914
NCT04203914已完成4 期

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

Yaounde Central Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Left ventricular diastolic function

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Intervention

Experimental

Empagliflozin 25mg daily add-on therapy

干预措施: Empagliflozin Tablets (Drug)

结局指标

主要结局

Left ventricular diastolic function

时间窗: 6 weeks

Doppler ultrasound measured relaxation

次要结局

  • HbA1c(6 weeks)
  • Blood pressure(6 weeks)

研究者

发起方
Yaounde Central Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sobngwi Eugene

Medical Advisor

Yaounde Central Hospital

研究点 (2)

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