NCT03092843已完成不适用
Functional Capacity and Quality of Life Following SePtal Myectomy in patIents With Obstructive hypeRtrophIc cardiomyopaThy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Change in Quality of Life Change in Summary Score
研究概览
简要总结
Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.
详细描述
The objective of this study is to examine change in quality of life and functional capacity as respectively measured by, Quality of Life Questionnaires and six-minute walk test distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy, as compared to prior to surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo septal myectomy.
- •Established diagnosis of obstructive HCM defined as:
- •LVH Thickness ≥15mm left ventricular outflow tract gradient ≥50mmHg
排除标准
- •Prior septal myectomy or alcohol septal ablation
- •Prior myocardial infarction
- •Uncontrolled arrhythmias including ventricular tachycardia and atrial fibrillation
- •Uncontrolled hypertension
- •Angiographically documented coronary stenosis >50%, if available at time of screening
- •Inability to provide informed consent
- •Inability to walk without assistive devices
- •Peripheral artery disease with claudication
结局指标
主要结局
Change in Quality of Life Change in Summary Score
时间窗: 1 year post myectomy
Mild improvement in Quality of Life summary score (increase in 5 points) as measured by Kansas City Cardiomyopathy Questionnaire -KCCQ
次要结局
- Change in Quality of Life Change in Patient Reported Outcomes(1 year post myectomy)
- Change in Quality of Life Change in Duke's Activity Status Index (DASI)(1 year post myectomy)
- Change in functional capacity post myectomy(1 year post myectomy)
研究者
研究点 (1)
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