跳至主要内容
临床试验/CTRI/2024/09/074343
CTRI/2024/09/074343招募中Phase 3 4

Sacubitril Valsartan versus Telmisartan in remodeling of left ventricleafter acute anterior wall myocardial infarction

Government medical college and hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年10月11日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
To monitor LV remodelling (i.e. increase in LVEDV by more than 20% occuring anytime over a period of one year) among the patients with AMI receiving sacubitril valsartan or telmisartan.

研究概览

简要总结

: The study will be conducted in the Department of Cardiology at Government Medical College and Hospital (GMCH), Chandigarh. Patients of Acute Anterior wall Myocardial Infarction attending the cardiology Outpatient department or being admitted from emergency will be enrolled. Randomization will be done within 7 days of acute MI into two groups. Group A patients will start on sacubitril valsartan. Group B patients will be managed with Telmisartan-based therapy . Patients will be followed up at 6 and 12 months with repeated investigations including cardiac biomarkers and Echocardiography to monitor  LV Remodeling in both repeated groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 70 years.
  • Patients with Acute Anterior Wall Myocardial Infarction within past 7 days.
  • undergoing coronary angiography.
  • Adequate echocardiographic image quality.
  • Availability of a follow-up evaluation at 6 and 12 months.

排除标准

  • Previous heart failure.
  • Renal dysfunction with eGFR of less than 60 ml per minute per 1.73 m
  • History of angioedema.

结局指标

主要结局

To monitor LV remodelling (i.e. increase in LVEDV by more than 20% occuring anytime over a period of one year) among the patients with AMI receiving sacubitril valsartan or telmisartan.

时间窗: To monitor LV remodelling (i.e. increase in LVEDV by more than 20% occuring anytime over a period of one year) among the patients with AMI receiving sacubitril valsartan or telmisartan. | time points are 6 months and 12 months

次要结局

  • To compare the changes in levels of cardiac biomarkers(Troponin I and BNP) among the patients with AMI receiving sacubitril valsartan or telmisartan at baseline, 6 months and after one year.(To compare the changes in levels of cardiac biomarkers(Troponin I and BNP) among the patients with AMI receiving sacubitril valsartan or telmisartan at baseline, 6 months and after one year.)

研究者

发起方
Government medical college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Amitoj singh sagoo

Government medical college and hospital

研究点 (1)

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