Withdrawal of Spironolactone Treatment for Heart Failure With Improved Left Ventricular Ejection Fractraction: an Open-label Randomized Controlled Pilot Study (With-HF Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change of left ventricular ejection fraction
研究概览
简要总结
The study is a randomized controlled pilot trial to evaluate whether withdrawal of spironolactone is safe and associated with re-deterioration of left ventricular function in patients with heart failure with improved ejection fraction. The aim of current trial is to test the hypothesis that withdrawal of spironolactone would not be associated with relapse of significant clinical deterioration of left ventricular systolic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and capable of providing informed consent and agrees to follow the study protocol and schedule of clinical follow-up
- •Age between 19 and 80 years old
- •Prior diagnosis of heart failure with reduced left ventricular ejection fraction (LV EF ≤ 35%) and on medical therapy including spironolactone combined with angiotensin-converting enzyme or angiotensin receptor blocker or antiotensin receptior neprilysin blocker, beta-blocker.
- •LV EF ≥ 50% documented with echocardiography performed within a month
- •Documented result of BNP or NT-proBNP level within a month
排除标准
- •Dyspnea ≥ New York Heart Association (NYHA) functional class III
- •Patients who need to discontinue spironolactone owing to prior adverse event
- •Primary valvular heart disease with at least moderate degree
- •Estimated glomerular filtration rate less than 30 mL/min per 1.73 m2
- •Uncontrolled hypertension defined as blood pressure more than 140/90 mmHg
- •Presence of other clinical reason to continue spironolactone such as myocardial infarction, primary aldosteronism, and liver cirrhosis
- •Hyperkalemia defined as serum potassium level less than 3.5 mmol per liter
- •Pregnant and/or lactating women
- •Life expectancy less than a year
- •Patients who are not suitable to enrollment by investigator's discretion
研究组 & 干预措施
Withdrawal group
Spironolactone will be discontinued in patients who were receiving optimal medical therapy including angiotensin-converting enzyme or angiotensin receptor blocker or angiotensin receptor neprilysin, beta-blocker, and spironolactone.
干预措施: Withdrawal of Spironolactone (Drug)
Continuation group
Spironolactone will be continued during the study period with other medical therapy in combination.
干预措施: Continuation of spironolactone (Drug)
结局指标
主要结局
Change of left ventricular ejection fraction
时间窗: 6 month
Proportion of patients with change of left ventricular ejection fraction declining more than 10%
次要结局
- Numerical change of left ventricular ejection fraction(6 month)
- Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide(6 months)
- Change of serum level of biomarkers (e.g. soluble ST-2, galectin-3)(6 months)
- Rates of death, re-hospitalization or visit on emergency department for heart failure(6 months)
- results of each outcomes during extended follow-up period(2 years)
研究者
Sang Eun Lee
professor of medicine
Asan Medical Center