Improving Outcomes in Atrial Fibrillation Patients Aided by Implantable Cardiac Monitor: Evaluation of Chronic Beta-blocker Use Versus As-needed Pharmacological Rate Control
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Exercise capacity
研究概览
简要总结
The goal of this study is to test the feasibility of guiding as-needed pharmacological rate control of atrial fibrillation (AF) by implantable cardiac monitors and to assess the impact of continuous beta-blocker therapy versus as-needed rate control on the following outcomes:
(1) exercise capacity, (2) AF burden, (3) symptomatic heart failure, (4) biomarker assessment of cardiac filling pressures and cardio-metabolic health, and (5) quality of life in patients with atrial fibrillation and stage II or III heart failure with preserved ejection fraction.
详细描述
Patients ≥ 18 years of age with paroxysmal or persistent AF who have an implantable cardiac monitor (either loop recorder or pacemaker) and who are receiving daily beta-blocker therapy will be screened for meeting the inclusion/exclusion criteria.
Trial participants will then be randomized into the daily beta-blocker or as-needed pharmacological rate control.
At baseline and six months trial participants will undergo assessment of the following measures:
- Assessment of Quality of life using the Minnesota Living with Heart Failure Questionnaire and the Atrial Fibrillation Effect on Quality of life Questionnaire.
- Blood draw
- Cardiopulmonary exercise test, 6 Minute Walk Test and average daily activity level via integrated accelerometer of the implantable cardiac monitor (if available).
- Assessment of AF burden
Study participants may opt into long-term follow up visits at 12, 18 and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal or persistent AF diagnosed in the past 4 weeks or longer
- •Implantable cardiac monitor (either loop recorder or pacemaker)
- •Current treatment with greater than minimum doses of beta-blockers OR any beta-blocker with resting sinus rhythm heart rate < 75 bpm (documented on EKG in the last 6 months OR at enrollment visit)
- •Left ventricular ejection fraction ≥ 50% (reported on echocardiogram within the past 48 months)
- •Echocardiographic evidence of structural changes consistent with HFpEF defined by (1) left ventricular hypertrophy (septal or posterior wall thickness > 10mm) OR (2) left atrial enlargement OR (3) diastolic dysfunction.
排除标准
- •Long-standing persistent or permanent atrial fibrillation (Long-standing persistent AF is defined as continuous AF of > 12 months duration. Permanent AF is defined as AF accepted by the patient and physician and no further attempts to restore/maintain sinus rhythm will be undertaken).
- •Echocardiographic evidence of left ventricular dilation (defined as left ventricular end diastolic volume (LVEDV) index ≥ 80ml/m2 as determined by echocardiogram within the past 48 months.
- •Documentation in the electronic medical record suggesting a life expectancy less than 12 months
- •Minimum dosage of beta-blocker therapy to meet enrollment criterion:
- •Metoprolol tartrate 25mg twice daily, Metoprolol succinate 50mg daily, Carvedilol 12.5mg daily, Bisoprolol 5mg twice daily, Nebivolol 5mg daily, Atenolol 50mg daily, Labetalol 100mg twice daily, Propranolol 40mg twice daily
研究组 & 干预措施
As needed rate control
Patients randomized to the experimental arm will stop their daily beta-blocker and take as needed rate control guided by their implantable cardiac monitor
干预措施: As needed pharmacological rate control with beta-blocker (metoprolol tartrate, metoprolol succinate) or calcium channel blocker (diltiazem, verapamil) (Drug)
结局指标
主要结局
Exercise capacity
时间窗: At time of randomization and 6 months afterwards.
Change in peak oxygen consumption during cardiopulmonary exercise testing
次要结局
- Number of participants with a composite of treatment related adverse events(At 6 months, at 12 months, at 18 months, at 24 months)
研究者
Nicole Habel, MD
Principal Investigator
University of Vermont