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临床试验/EUCTR2017-002020-25-DK
EUCTR2017-002020-25-DK进行中(未招募)1 期

ANGIOTENSIN–NEPRILYSIN INHIBITION IN DIASTOLIC DYSFUNCTION AFTERAMI

Odense University Hospital0 个研究点目标入组 100 人开始时间: 2018年5月18日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Key inclusion criteria:
  • 1. Documented ST segment or non ST segment elevation AMI,
  • 2. Complete revascularization.
  • 3. Age >=50 years
  • 4. LVEF >=45% on echocardiography performed within 72 hours of the AMI.
  • 5. Diastolic dysfunction defined as: Ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e’) ratio > 8 and LA dilatation (LA volume
  • index>34 mL/m2).
  • 6. Signed informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 34
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 66

排除标准

  • 1. Known history of cardiomyopathy, and or moderate/severe valvular heart disease,
  • 2. Severe obstructive or restrictive pulmonary disease,
  • 3. Inability to perform exercise testing/ inadequate acoustic windows on echocardiography,
  • 4. Class I indication for an angiotensin converting enzyme inhibitor.
  • 5. A systolic blood pressure of less than 100 mm Hg at screening
  • 6. An estimated glomerular filtration rate (eGFR) below 30 ml per minute per 1.73 m2 of
  • body-surface area at any time,
  • 7. A serum potassium level of more than 5.2 mmol per liter at screening,
  • 8. A history of angioedema or unacceptable side effects during receipt of angiotensin
  • converting enzyme inhibitor or angiotensin receptor blocker
  • 9. Inability to provide informed consent

研究者

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