An Observational, Cross-sectional, Multicenter Study Evaluating the Correlation Between Quality of Life and Aerobic Physical Fitness of Patients With a Systemic Right Ventricle.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation between the short form SF-36 scores and maximum oxygen uptake (peak VO2)
研究概览
简要总结
Congenital heart disease (CHD) is the most common congenital malformations. The right ventricle in the sub-aortic position, or "systemic right ventricle" is one of these complex cardiac diseases. Several studies show that adults with CHD and especially systemic right ventricle have reduced exercise capacity. In addition, studies have shown that there is a correlation between alteration of aerobic physical capacity and alteration of right ventricular systolic function.
Understanding and assessing the determinants of the physical capacity of patients with systemic right ventricles and evaluating their quality of life could allows us to improve their therapeutic management and also to expand patient indications to a program cardiac rehabilitation. This can benefit them on their exercise capacity, their tolerance to exercise and their quality of life.
The aim is to study the correlation between the quality of life and the aerobic physical fitness of patients with a systemic right ventricle and to determine the clinical and paraclinical parameters that have an impact on the aerobic physical fitness of these patients. The quality of life of patients with a systemic right ventricle will be compared to that of the general population.
详细描述
100 patients will be enrolled in this study. 25 sites will participate to the enrollment, belonging to the French national network for complex congenital heart diseases (M3C) .
Patient is included during his annual medical check-up. Quality of life questionnaire and other examinations are performed during this site visit. Its is a part of his usual care. No supplementary visit, directly related to the research, are necessary.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient over 18 years of age
- •Patient with a right ventricle in the systemic position
- •Patient having undergone an annual assessment in accordance with the ESC (European Society of Cardiology) 2010 recommendations: clinical examination, ECG, echocardiography, cardiopulmonary exercise test (with VO2)
排除标准
- •Objection of the patient
- •Impossibility of performing an exercise test
- •Inability to understand and / or complete the questionnaire
结局指标
主要结局
Correlation between the short form SF-36 scores and maximum oxygen uptake (peak VO2)
时间窗: First day
次要结局
未报告次要终点