NCT06715137已完成不适用
Microvascular Dysfunction in Adults with Congenital Heart Disease and the Effect of Exercise Training
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Coronary microvascular function: coronary flow reserve
研究概览
简要总结
The goal of this prospective cohort study is to deepen the understanding of the pathophysiology in adults with congenital heart disease (CHD). Through this research, the investigators aim to identify potential strategies to improve the prevention and treatment of these patients. In this context, the effects of exercise training will also be assessed. The main questions it aims to answer are:
- Is coronary microvascular dysfunction (MVD) present in adults with diverse types of CHD?
- Is peripheral MVD present in adults with diverse types of CHD?
- Are coronary and peripheral MVD correlated in adults with diverse types of CHD?
- Is microvascular function correlated with inflammation and oxidative stress in adults with diverse types of CHD?
- Are inflammation and oxidative stress correlated with ventricular function in adults with diverse types of CHD?
- Are MVD and diminished ventricular function interrelated and associated with reduced exercise capacity in adults with diverse types of CHD?
- Does exercise training in adults with CHD result in improvements in coronary and peripheral microvascular function, inflammation and oxidative stress, biventricular function, muscle strength, exercise capacity and quality of life?
For the last research question, patients were randomized to receive either conventional care or home-based aerobic and strength exercise training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
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
- 是
入选标准
- •adults with congenital heart disease: as many different types of CHD as possible were incorporated
- •New York Heart Association (NYHA) class I-II
- •who visited the out-patient clinic at the Antwerp University Hospital
排除标准
- •body mass index >35 kg/m²
- •professional endurance athlete
- •the presence of macrovascular coronary artery disease
- •diabetes mellitus
- •a systemic disease (e.g., malignancies, acute and chronic inflammatory diseases in the preceding 3 months)
- •a contraindication for adenosine administration.
结局指标
主要结局
Coronary microvascular function: coronary flow reserve
时间窗: on both study visits (at baseline and at 16 weeks)
The coronary flow reserve (CFR) was measured using pulsed wave Doppler measurements at the mid to distal left anterior descending artery (LAD) in an apical modified 2-chamber view. At baseline and during hyperemia (following a 3-minute period of intravenous adenosine administration at a rate of 140 µg/kg/min), three optimal profiles of peak diastolic Doppler flow velocities were measured, and the results were averaged. CFR was then calculated as the ratio between hyperemic and basal average peak velocities.
次要结局
- Peripheral microvascular function: reactive hyperemia index(on both study visits (at baseline and at 16 weeks))
- Peripheral microvascular function: Framingham modified reactive hyperemia index(on both study visits (at baseline and at 16 weeks))
- Carotid arterial wall thickness: carotid intima-media thickness(on both study visits (at baseline and at 16 weeks))
- Large artery stiffness: pulse wave velocity(on both study visits (at baseline and at 16 weeks))
- Large artery stiffness: augmentation index(on both study visits (at baseline and at 16 weeks))
- Inflammation: white blood cell count(on both study visits (at baseline and at 16 weeks))
- Inflammation: high-sensitivity C-reactive protein(on both study visits (at baseline and at 16 weeks))
- Oxidative stress: superoxide anion radical(on both study visits (at baseline and at 16 weeks))
- Left ventricular function: ejection fraction(on both study visits (at baseline and at 16 weeks))
- Left ventricular function: global longitudinal strain(on both study visits (at baseline and at 16 weeks))
- Right ventricular function: fractional area change(on both study visits (at baseline and at 16 weeks))
- Right ventricular function: tricuspid annular plane systolic excursion(on both study visits (at baseline and at 16 weeks))
- Right ventricular function: tissue Doppler imaging systolic velocity(on both study visits (at baseline and at 16 weeks))
- Right ventricular function: peak systolic global longitudinal strain(on both study visits (at baseline and at 16 weeks))
- Quality of life: RAND 36-Item Health Survey 1.0(on both study visits (at baseline and at 16 weeks))
- Quality of life: EuroQol visual analogue scale(on both study visits (at baseline and at 16 weeks))
- Exercise capacity: percent-predicted peak oxygen consumption(on both study visits (at baseline and at 16 weeks))
- Muscle strength: one-repetition maximum(on both study visits (at baseline and at 16 weeks))
研究者
研究点 (2)
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