Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction Before and After Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in peak VO2
研究概览
简要总结
In a prospective, observational pilot study of patients scheduled for an atrial fibrillation (AF) ablation at the University of Vermont Medical Center the investigators will compare exercise capacity before and four months after AF ablation.
详细描述
Patients ≥ 18 years of age who are scheduled for an AF ablation at the University of Vermont Medical Center will be screened for the following inclusion criteria: H2FpEF score of ≥ 6 (corresponding to ≥90% probability of HFpEF (19)) AND echocardiogram within the past 2 years that reported a LV ejection fraction ≥ 50% AND at least one symptom of HF (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea). Exclusion criteria: (1) Life expectancy <12 months, (2) moderate or more valvular disease, (3) inability to walk on a treadmill. Patients with early recurrent AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 110 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •H2FpEF score of ≥ 6 (corresponding to >90% probability of HFpEF (19))
- •echocardiogram within the past 2 years that reported a LV ejection fraction ≥ 50%
- •at least one symptom of HF (dyspnea on exertion, orthopnea or paroxysmal nocturnal dyspnea).
- •AF ablation scheduled at UVMMC
排除标准
- •Life expectancy <12 months
- •moderate or more valvular disease
- •inability to walk on a treadmill
结局指标
主要结局
Change in peak VO2
时间窗: before AF ablation and 4 months after AF ablation
cardiopulmonary exercise testing will be performed \& peak VO2 measured at baseline \& follow up visit
次要结局
- Change in KCCQ score(before and 4 months after AF ablation)
- Percent change in NTproBNP(before and 4 months after AF ablation)
研究者
Nicole Habel, MD
Principal Investigator
University of Vermont
