The Effect of Beta-blocker on Chronotropic Response and Cardiorespiratory Fitness in Patients With Atrial Fibrillation: a Crossover Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Peak oxygen intake
研究概览
简要总结
This is a prospective study to evaluate changes in exercise capacity and chronotropic response to exercise before and after beta-blocker dosage reduction in patients with atrial fibrillation (AF).
详细描述
Rate control therapy is the first-line treatment for atrial fibrillation (AF). Resting heart rate(HR) is the treatment target of rate control therapy in current clinical practice; However, the optimal value for resting heart rate in AF remained unclear. Beta-blocker(BB) is widely used as rate-control agent. It is concerned that excessive use of BB might lead to a negative effect on exercise capacity in patients with AF. The aim of this study is to explore the effect of Beta-blocker on hemodynamic parameters and peak oxygen uptake during cardiopulmonary exercise test (CPET).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor are blinked to participants' allocation group.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 20 years of age.
- •Clinically stable patients with persistent atrial fibrillation using beta-blocker as rate-control agent without dosage adjustment for at least 3 months.
- •Resting heart rate < 80 bpm.
- •Left ventricular ejection fraction > 50%.
排除标准
- •Beta-blocker usage due to indications other than rate control for atrial fibrillation.
- •Inability to perform a cardiopulmonary exercise testing.
- •Presence of contraindications for cardiopulmonary exercise testing according to the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
- •Patients with implantable cardioverter defibrillator or pacemaker.
- •Inability to provide informed consent.
研究组 & 干预措施
Arm A
Phase I : Participants will undergo first CPET (Day 0) at trough concentration of BB. After 7-day regular usage of BB, the second CPET(Day 7) will be performed at peak concentration of BB. Participants will enter the second phase if the results of CPET fulfill the pre-determined conditions as follows: (1) Chronotropic index < 0.8 at peak level of BB, (2) Resting HR < 110 bpm at trough level of BB, (3) Absent of unstable arrhythmia or unstable hemodynamics during CPET at trough level.
Phase II: BB dosage will be reduced. Daily blood pressure, heart rate and adverse event will be recorded. If participants remained clinically stable, the third CPET(Day 21) will be performed 14 days after the reduction of dosage. If participants' resting heart rate exceed 110 bpm, the dosage will be adjusted to the original level.
干预措施: Reduced dosage of beta-blocker (Drug)
Arm B
Phase I : Participants will undergo first CPET(Day 0) at peak concentration of BB. After 7-day regular usage of BB, the second CPET(Day 7) will be performed at trough concentration of BB. Participants will enter the second phase if the results of CPET fulfill the pre-determined conditions as follows: (1) Chronotropic index < 0.8 at peak level of BB, (2) Resting HR < 110 bpm at trough level of BB, (3) Absent of unstable arrhythmia or unstable hemodynamics during CPET at trough level.
Phase II: BB dosage will be reduced. Daily blood pressure, heart rate and adverse event will be recorded. If participants remained clinically stable, the third CPET(Day 21) will be performed 14 days after the reduction of dosage. If participants' resting heart rate exceed 110 bpm, the dosage will be adjusted to the original level.
干预措施: Reduced dosage of beta-blocker (Drug)
结局指标
主要结局
Peak oxygen intake
时间窗: The change in peak oxygen uptake will be measured at day 0 , day 7 and day 21.
Peak oxygen intake will be assessed with symptom-limited cardiopulmonary exercise testing.
Chronotropic response to exercise
时间窗: The change in chronotropic response to exercise will be measured at day 0 , day 7 and day 21.
Plasma norepinephrine level was obtained before and immediately after cardiopulmonary exercise testing to assess the relationship of beta-blocker, circulating norepinephrine level and chronotropic response to exercise.
次要结局
- NT-proBNP(The change in NT-proBNP will be measured at day 0 , day 7 and day 21.)
- Quality of life evaluation(The change in SF-36 will be measured at day 0 , day 7 and day 21.)
- European Heart Rhythm Association (EHRA) symptom scale(The change in European Heart Rhythm Association (EHRA) score will be measured at day 0 , day 7 and day 21.)
- Cardiac output and stroke volume(The change in cardiac output and stroke volume will be measured at day 0 , day 7 and day 21.)
- Cognitive function(The change in MoCA will be measured at day 0 , day 7 and day 21.)