Feasibility and Safety of Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients With Atrial Fibrillation (DASH-AF)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- intravenous loading regimen followed by q12h oral sotalol administration
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of the IV loading strategy in patients who are selected to receive sotalol.
详细描述
This is an open-label single arm study investigating the safety and feasibility of an intravenous loading regimen of sotalol to initiate patients on oral sotalol therapy. Informed Consent will be obtained from all patients prior to enrollment in the study. Patients will be admitted to the hospital in accordance with standard hospital protocol for oral sotalol loading.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female between 18 - 85 years old
- •Recent (within 1 day) cardioversion for atrial fibrillation with scheduled sotalol therapy
- •History of highly symptomatic atrial fibrillation who are scheduled for sotalol therapy
- •Creatinine clearance ≥60 mL/min
- •Subject has provided informed consent prior to initiation of any study-specific activities/procedures
排除标准
- •Baseline bradycardia (<50 bpm) off all antiarrhythmic drugs and or Atrioventricular nodal blocking drugs
- •Sick sinus syndrome, unless a functioning pacemaker is present.
- •Any known sensitivities to beta-blockers
- •Uncontrolled heart failure
- •Second-degree (Mobitz II, Wenckebach) or third-degree atrioventricular block
- •Recent (within 7 days) surgical or catheter ablation procedure
- •Severe electrolyte abnormalities (including serum K<3.5)
- •Known use of other QTc prolonging drugs (See Appendix A)
- •Recent (within 7 days) sotalol use
- •Baseline QTc >450 ms
- •Severe reactive airway disease - defined as difficulty breathing from bronchial tubes, swelling and overreaction to an irritant
- •History of Torsade de Pointes (TdP)
- •Pregnancy or breastfeeding
- •Left ventricular ejection fraction (LVEF) less than 35%
研究组 & 干预措施
DASH-AF
Patients with history of highly symptomatic persistent or paroxysmal AF who are scheduled for sotalol therapy once in sinus rhythm will be enrolled in this study.
干预措施: Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation (Drug)
结局指标
主要结局
intravenous loading regimen followed by q12h oral sotalol administration
时间窗: 3 months
The hypothesis to be tested is that the intravenous loading regimen followed by q12h oral sotalol administration will result in sotalol concentration and QTc peaks on day 1 (IV to oral loading) which are comparable to the steady-state and maximum QTc seen on Day 3 (steady-state).
次要结局
未报告次要终点