ACTRN12621000896875已完成未知
WITHDRAWal of heart failure directed therapies in recovered Atrial Fibrillation mediated cardiomyopathy- investigating the impact on left ventricular ejection fraction: the WITHDRAW-AF study
Alfred Hospital0 个研究点目标入组 60 人开始时间: 2021年7月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Age>18 years
- •- AF mediated cardiomyopathy
- •Previous LVEF <40% in the setting of AF with recovery to >50% within 6 months after
- •restoration of sinus rhythm (with anti-arrhythmic medications, electrical cardioversion,
- •catheter ablation or any combination of these)
- •- NYHA class I
- •- Currently on pharmacological anti-heart failure therapy including at least 2 of:
- •-ACE inhibitor or Angiotensin receptor antagonist
- •-Diuretic (excluding MRA)
- •-Cardiac specific beta blocker
- •-Mineralocorticoid receptor antagonist
- •-Entresto (Sacubitril/Valsartan)
- •- No recurrence of AF with previous 6 months
- •- No heart failure related admissions with last 6 months
- •- Cardiac MRI demonstrating
- •-LVEF >/=50%
- •-The absence of ventricular late gadolinium enhancement
- •-Indexed LVEDV less than 10% upper limit of normal
- •- Able to consent
- •- Willing to adhere to follow up requirements
排除标准
- •- Patients with unsuccessful rhythm control
- •- Patients with known contributing cause of LV dysfunction including
- •-Ischaemic cardiomyopathy
- •-Valvular heart disease
- •-Hypertrophic cardiomyopathy
- •-Uncontrolled current/ongoing alcohol intake
- •-Other cause of cardiomyopathy (eg thyroid disease)
- •- Significant renal impairment (eGFR<30mL/min/1.73m2)
- •- Contraindication to
- •-cardiac MRI,
- •-catheter ablation or
- •-anti-coagulation
- •- Any condition with expected survival < 2 years
- •- Patients with a clear indication for ACE/ARB therapy for reasons other than heart failure where alternative agents are contra-indicated or inappropriate
- •- Unable to provide informed consent
研究者
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