Tapering Heart Failure Medication in Patients with Heart Failure with Recovered Ejection Fraction; Open Label Prospective Random Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Heart failure relapse
研究概览
简要总结
Study start date is on Nov 27th 2024.
A patient with an initial ejection fraction (EF) of less than 40%, whose follow-up shows an improvement to an EF of 50% or higher, along with the left ventricular end-diastolic diameter returning to the normal range and taking 3 more heart failure medication randomed to drug tapering group ( RAS blocker or beta blocker) or continuing medication group.
详细描述
Patients described above randomly assigned to drug tapering group and drug maintaining group.
Drug tapering group is 2 groups, which one is RAS blocker tapering group and others is beta blocker tapering group.
Drug tapering group is monitored ejection fraction, LV dimension and LV GLS by 1-3 month.
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
- Single (Outcomes Assessor)
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
- •initial echocardiogram ejection fraction less than 40%
- •follow up echocardiogram ejection fraction over 50% and LVEDD index normal range
- •NTprobnp criteria
- •eGFR ≥60 ; less 440
- •eGFR 45-59: less 980
- •eGFR 30-44; less 1220
- •eGFR < 30 : less 5300
- •in HD; no criteria for NTproBNP
- •on more than 3 heart failure medication ( RAS blocker, beta blocker, mineral corticoid receptor antagonist, SGLT 2 inhibitor)
排除标准
- •under age 18 year
- •uncontrolled BP ( over 150/90)
- •coronary revascularization within 6 months
- •significant valve disease
- •arrhythmia requiring rate control
- •CKD with albuminuria ( over 30mg/g)
研究组 & 干预措施
RAS blocker tapering arm
RAS blocker tapering
干预措施: RAS blocker tapering group (Drug)
RAS blocker tapering arm
RAS blocker tapering
干预措施: Beta blocker tapering out (Drug)
Beta blocker tapering arm
Beta blocker tapering arm
干预措施: RAS blocker tapering group (Drug)
Beta blocker tapering arm
Beta blocker tapering arm
干预措施: Beta blocker tapering out (Drug)
Control
Drug maintain group
干预措施: RAS blocker tapering group (Drug)
Control
Drug maintain group
干预措施: Beta blocker tapering out (Drug)
结局指标
主要结局
Heart failure relapse
时间窗: From enrollment to the end of treatment at 18 months
LVEF 10% drop, EF less than 50 %, LVIDd/BSA 10% increase, over 33mm/m\^2
次要结局
未报告次要终点