CTRI/2020/12/029913尚未招募3 期
Sacubitril Valsartan vs. Angiotensin Converting Enzyme Inhibitor for chronic rheumatic mitral regurgitation : A Randomised Controlled Trail
All India Institute of Medical Science Rishikesh0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •Asymptomatic or minimally symptomatic rheumatic severe mitral regurgitation
- •Not a candidate for surgery
排除标准
- •History of hypersensitivity or allergy to the study drug or contraindications to the study drug
- •Known history of angioedema
- •Current acute decompensated heart failure or dyspnea of NYHA class
- •Medical history of hospitalization within 6 weeks
- •Symptomatic hypotension and/or a SBP < 100 mmHg at screening
- •Estimated GFR < 30 mL/min/1.73m2
- •Serum potassium > 5 mmol/L at screening
- •Evidence of hepatic disease as determined by any one of the f ALT values exceeding 2 x upper limit of normal (ULN) at screen history of hepatic encephalopathy, history of esophageal varice portacaval shunt
- •Acute coronary syndrome, stroke, major CV surgery, Percutaneous intervention
- •Planned coronary revascularization or mitral valve intervention
- •Heart transplantation or implantation of cardiac resynchronization
- •History of severe pulmonary disease
- •Significant aortic valve disease
- •Primary aldosteronism
- •Women of child-bearing potential, defined as all women physio capable of becoming pregnant, unless they are using a barrier hormonal method
- •Pregnant or nursing (lactating) women
- •Any clinically significant abnormality identified at the screening examination, laboratory tests, or electrocardiogram which, the the investigator, would preclude safe completion of the study
- •Atrial Fibrillation
- •Pulmonary Artery Pressure > 50 mm Hg 20 . LV end systolic dimension > 40 mm 21. LVEF < 50 %
研究者
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