KCT0005034已完成未知
Withdrawal of spironolactone treatment for heart failure with improved left ventricular ejection fraction: an open-label randomized controlled pilot study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 62
研究概览
简要总结
In this study, we confirmed that MRA can be safely discontinued in heart failure patients whose left ventricular ejection fraction has improved to over 50%, and that the risk of worsening cardiac dysfunction after stopping is low.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1.Subject who was diagnosed with heart failure and reduced LV EF (HFrEF; LV EF = 35 %) and aged between 19 and
- •80 years old
- •2.Subject who was on medical therapy for heart failure management including spironolactone combined with ACEIs or
- •ARBs or ARNI or beta-blockers
- •3.LV EF = 50% documented with echocardiography performed within a month from screening period
- •4.Subject who has documented result of BNP or NT-proBNP level within a month from screening period
- •5.Subject who agrees to written consent voluntary
排除标准
- •1.Dyspnea = New York Heart Association (NYHA) functional class III
- •2.Subject who needs to discontinue spironolactone owing to prior adverse event
- •3.Estimated glomerular filtration rate less than 30 mL/min per 1.73 m2
- •4.Uncontrolled hypertension defined as blood pressure more than 140/90 mmHg
- •5.Primary valvular heart disease with at least moderate degree
- •6.Presence of other clinical reason to continue spironolactone such as myocardial infarction, primary aldosteronism, and liver cirrhosis
- •7.Hyperkalemia defined as serum potassium level less than 3.5 mmol per liter
- •8.Pregnant and/or lactating women
- •9.Subject with life expectancy less than a year
- •10.Subject who is not suitable to enrollment by investigator’s discretion
研究者
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已完成
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进行中（未招募）
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进行中（未招募）
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