跳至主要内容
临床试验/NCT05727423
NCT05727423进行中(未招募)不适用

Safety and Efficacy of Dapagliflozin in the Treatment of Heart Failure in Non-diabetic Egyptian Patients

Helwan University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
45
试验地点
1
主要终点
left ventricular ejection fraction

研究概览

简要总结

prospectively evaluation the safety and efficacy of the Sodium-glucose Cotransporter-2 (SGLT2) inhibitor dapagliflozin in non-diabetic patients with heart failure and a reduced ejection fraction

详细描述

Heart failure (HF) is a complex clinical syndrome characterized by the reduced ability of the heart to pump and/or fill with blood. From a physiological point of view, HF can be defined as an inadequate cardiac output to meet metabolic demands.

HF is a growing public health problem, with an estimated 63 million people affected worldwide , with HF being the underlying cause of more than 1 million hospitalizations every year. These hospitalizations are associated with poor prognosis (50% rate of re-hospitalization within 6 months after discharge and around 33% rate of death within 12 months after discharge), In addition, the prevalence of patient with HF and reduced ejection fraction (HFrEF) is higher and has greater mortality rates than those with preserved ejection fraction (HFpEF).

Sodium-glucose Cotransporter-2(SGLT2) inhibitors are a novel class of anti diabetic agents that promote urinary glucose excretion by inhibiting glucose and sodium reabsorption from the renal proximal tubules and have recently been investigated in several large randomized controlled trials for cardiovascular safety and efficacy in patients with type 2 diabetes .

More recently, the DAPA-HF trial which showed that dapagliflozin significantly improved the outcomes of patients with HFrEF and reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% irrespective of the presence or absence of T2DM, demonstrated the significance of SGLT2 inhibitors as novel therapeutic agents in heart failure.

In May 2020,The FDA approved AstraZeneca's dapagliflozin (Forxiga) for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes (T2D), marking the first time a drug in a class developed for diabetes was approved for heart failure even if diabetes is not present.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients age > 18 years
  • Diagnosis of heart failure NYHA class II- IV
  • LVEF ≤ 40% on echocardiography

排除标准

  • Estimated glomerular filtration rate <30 ml/min/1.73m2
  • Pregnant or lactating women

结局指标

主要结局

left ventricular ejection fraction

时间窗: 6 months

Assessment of Echo parameters of LV-systolic function as EF

次要结局

  • left ventricular end-systolic volume, left ventricular end-diastolic volume(6 months)
  • E/e', LAVI, septal e'(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Madonna salama hanna

Teaching Assistant

Helwan University

研究点 (1)

Loading locations...

相似试验