The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Mean Arterial Pressure
研究概览
简要总结
The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frequent symptomatic premature ventricular contractions (PVCs) (>10% of total QRSs on a 24-hour Holter)
- •Willingness to participate in research
排除标准
- •Age > 65 years old
- •Pacemaker implantation
- •Implantable cardioverter defibrillator implantation requiring pacing
- •Sick sinus syndrome
- •Atrio-ventricular (AV) block
- •Left ventricular dysfunction defined as left ventricular ejection fraction < 50%
- •History of myocardial infarction or coronary artery disease
- •Severe left ventricular hypertrophy (wall thickness > 1.5 cm by echocardiography performed within 3 months from enrollment)
- •Severe liver dysfunction
- •Creatinine clearance of 35 mL/min/1.73 square meters or less
- •Pregnancy
- •Known hypersensitivity to the drug
- •QRS duration > 120 ms
- •Recent change in blood pressure medication within 30 days of enrollment
研究组 & 干预措施
PVC Suppression then Placebo
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
干预措施: PVC Suppression using Flecainide (Drug)
PVC Suppression then Placebo
This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
干预措施: No PVC Suppression using Placebo (Drug)
Placebo then PVC Suppression
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
干预措施: PVC Suppression using Flecainide (Drug)
Placebo then PVC Suppression
This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.
干预措施: No PVC Suppression using Placebo (Drug)
结局指标
主要结局
Change in Mean Arterial Pressure
时间窗: Baseline and 28 days
Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.
次要结局
- Change in Muscle Sympathetic Nerve Activity(Baseline and 28 days)