NCT05122962招募中不适用
Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Right Heart Remodeling
研究概览
简要总结
This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate (or greater) PR based on quantitative Doppler echocardiography.
- •Repaired TOF
- •Congenital Heart Disease diagnosis including but not limited to Ebstein's anomaly, coarctation of the aorta (COA), Fontan palliation, transposition of the great arteries, congenitally corrected transposition of the great arteries.
排除标准
- •Pregnant Women
- •Unable to undergo CMRI
结局指标
主要结局
Right Heart Remodeling
时间窗: 24 Months
Right Heart Remodeling measured via right atrial reservoir strain (%).
次要结局
- Incident arrhythmias(24 Months)
- Aerobic Capacity(24 Months)
研究者
Alexander C. Egbe
Principal Investigator
Mayo Clinic
研究点 (1)
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