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临床试验/NCT05376748
NCT05376748招募中不适用

Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction Before and After Ablation of Atrial Fibrillation

University of Vermont1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年4月15日最近更新:
适应症

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AF (defined as AF after a 12-week post-procedural blanking period accounting for post-ablation inflammation) will be withdrawn from the study and not proceed to the 4 month follow up visit.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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole Habel, MD

Principal Investigator

University of Vermont

研究点 (1)

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