跳至主要内容
临床试验/NCT06520891
NCT06520891招募中不适用

"The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease"

Fayoum University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease

研究概览

简要总结

correlate the serum level of statin and SGLT2i when given as polytherapy with HPLC in ischemic heart failure patients and their laboratory tests (cholesterol, LDL, HDL and TG...)

详细描述

This is a prospective study that will carried out in Department of cardiology, Faculty of Medicine, Fayoum University during the period from 1 April 2024 to 1 Juley 2024. The study includes 90 Outpatients Clinic patients who met the inclusion criteria. Patients will provide written informed consent before involving in this study.

  • we will split the 90 patients into three groups:
  1. 30 patients will take statin.
  2. 30 patients will take SGLT2i.
  3. 30 patients will take both of statin and SGLT2i.
  • By collecting their blood samples and calculate the serum level of statin by using HPLC and calculate plasma level of SGLT2i by using HPLC as baseline first then after three months to predict the effect of each drug to another one, we will follow their cholesterol, triglyceride, low density lipo-protein and high density lipo-protein and we will also inspect their adverse effects.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • we include patients established ischemic heart failure seen by a primary care provider to diagnose ischemic heart disease,
  • They assessed the use of statin with SGLT2i.

排除标准

  • We exclude patients with
  • liver dysfunction.
  • renal dysfunction.
  • fungal infection.
  • coagulation disorder.
  • Pts using drugs that interact with SGLT2i.
  • patients that will refuse to be enrolled in the Study or refuse to write informed consent.

研究组 & 干预措施

Patients has ischemic heart failure

30 patients will take statin.

干预措施: Statin and SGLT2i (Drug)

Patients has ischemic heart

30 patients will take both of statin and SGLT2i.

干预措施: Statin and SGLT2i (Drug)

Patients has heart disease

30 patients will take SGLT2i.

干预措施: Statin and SGLT2i (Drug)

结局指标

主要结局

The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease

时间窗: Three months of follow up

correlate the serum level of statin and SGLT2i when given as polytherapy with ECG in ischemic heart failure patients and their laboratory tests (cholesterol, LDL, HDL and TG...)

次要结局

未报告次要终点

研究者

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

Asmaa Mohamed Abdelkader

"The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease"

Fayoum University

研究点 (1)

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