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临床试验/CTIS2023-506634-70-00
CTIS2023-506634-70-00进行中(未招募)1 期

Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation (PRAISE-MR)

Ziekenhuis Oost Limburg0 个研究点目标入组 110 人开始时间: 2023年7月17日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
110

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

年龄范围
18 至 65+(—)
性别
All

入选标准

  • (1) Age > 18 years (2) NYHA class II to IV (3) Written informed consent (4) Left ventricular ejection fraction = 50% (5) Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures*, including raised natriuretic peptides** (6) = moderate functional MR assessed by TTE within the previous year

排除标准

  • (1) Systolic blood pressure < 100 mmHg (2) Potassium = 5.2 mmol/L (3) eGFR = 25 ml/min/1.73m² (4) History of angioedema or unacceptable side effects during receipt of ACE inhibitors or ARBs (5) Structural mitral valve disease and previous or planned mitral valve intervention (6) Already receiving ARNI (sacubitril-valsartan) therapy (7) Severe comorbid condition limiting life expectancy < 24 months or inability to perform a maximal CPETecho

研究者

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