Withdrawal of Beta- Blockers and ACE Inhibitors After Left Ventricular Systolic Function Recovery in Patient With Dilated Cardiomyopathy: A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of patients that become symptomatic
研究概览
简要总结
Randomized study of medication withdrawal in patients who have recovered LV function in Dilated Cardiomyopathy.
详细描述
Importance of the study:
There is a growing population of patients with dilated cardiomyopathy (DCM) who had recovered left ventricular (LV) systolic function on medical therapy. Recent studies have shown a favorable clinical course in patients with DCM1-4. The heart failure (HF) guidelines states that discontinuation of medical therapy in this group of patients may be considered based on expert opinion. The safety of withdrawal of medical therapy needs further studies.
Hypothesis:
In Patients with dilated cardiomyopathy (DCM) who had recovery of the LV systolic function to a normal EF >50%, medical therapy withdrawal is attainable without Clinical deterioration or recurrence of LV systolic dysfunction.
Objective
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with dilated cardiomyopathy (DCM) with an initial HFrEF < 40 % at presentation.
- •DCM with recovered LV function to > or = to 50% documented on 2 ECHO examinations, with the most recent ECHO examination within 1 year of enrolment.
- •Time from initial diagnosis of DCM more or equal to 24 month.
- •Last hospitalization for decompensated HF > 1year.
- •Exclusion criteria:
- •Ischemic cardiomyopathy
- •Other structural pathology such as: Hypertrophic cardiomyopathy, Valvular cardiomyopathy or congenital heart disease.
- •Last hospitalization for decompensated HF < 1year ago.
- •Previous sustained ventricle tachycardia or ventricle fibrillation (VF) arrest.
排除标准
- 未提供
研究组 & 干预措施
Treatment
Withdrawal of beta blockers and ACE inhibitors
干预措施: withdrawal (Drug)
control
no withdrawal, standard of care
干预措施: standard of CARE (Drug)
结局指标
主要结局
Number of patients that become symptomatic
时间窗: 1 year
次要结局
- Number of patients that drop EF to <45%(1 year)
研究者
Nadia Giannetti
Chief, Division of Cardiology, Director of Heart Function Clinic
McGill University