Pretreatment With Atropine to Reduce Exercise-triggered Ventricular Ectopy in Patients With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)
研究概览
简要总结
To test the hypothesis that increasing the sinus node rate with atropine treatment prior to exercise will reduce exercise-triggered ventricular ectopy compared to baseline in patients with CPVT.
详细描述
This is a prospective cross-over trial that will enroll eligible patients with CPVT and perform a baseline treadmill exercise tolerance test (ETT) followed by a repeat treadmill ETT with I.V. atropine administered immediately prior to exercise. Atropine is a parasympathetic blocker and results in sinus tachycardia, which is expected to reduce the diastolic interval thereby reducing delayed after depolarizations and ventricular ectopy compared to baseline. Both ETTs will be performed on the same day with two hours of rest scheduled between ETTs. The primary analysis will be a paired comparison of the number of ventricular ectopic beats recorded during exercise (and recovery) at baseline and following pre-treatment with atropine. Secondary endpoints will include the presence of ventricular ectopy (yes/no), complex ventricular ectopy (couplets or greater, yes/no), and the number of runs of complex ventricular ectopy.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 6 years
- •Able to provide written informed consent
- •Clinical diagnosis of CPVT
- •Able to exercise on a treadmill
- •Successful completion of a minimum of 2 exercise stress tests without adverse events
排除标准
- •Contraindication to treadmill stress testing according to Vanderbilt University Medical Center's clinical protocols (unstable angina, decompensated congestive heart failure, severe hypertension (≥ 170/90 mmHg), acute myocardial infarction (<4 days), moderate to severe aortic stenosis, acute pulmonary embolism, severe pulmonary hypertension, outflow tract obstruction, hypertrophic cardiomyopathy, left main coronary stenosis, left bundle branch block)
- •Females who are pregnant
- •In the judgement of the investigator, any clinically significant ongoing medical or surgical condition that might jeopardize the subject's safety or interfere with the conduct of the study
研究组 & 干预措施
Treadmill then Treadmill with Atropine
Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine
干预措施: Atropine (Drug)
Treadmill then Treadmill with Atropine
Patients will undergo treadmill exercise at baseline, then Patients will undergo treadmill exercise after IV atropine
干预措施: Exercise treadmill test (Procedure)
结局指标
主要结局
Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)
时间窗: 20 minutes during exercise
次要结局
未报告次要终点
研究者
Prince Joseph Kannankeril
Associate Professor
Vanderbilt University