EUCTR2017-002020-25-DK进行中(未招募)1 期
ANGIOTENSIN–NEPRILYSIN INHIBITION IN DIASTOLIC DYSFUNCTION AFTERAMI
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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