Utilizing Exercise Cardiovascular and Skeletal Magnetic Resonance Imaging to Evaluate Factors Associated With Cardiorespiratory Fitness in Children With Acquired and Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- MRI assessment of cardiac structure at rest
研究概览
简要总结
There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function.
详细描述
Exercise cardiac MRI's are the non-invasive gold standard for assessing biventricular function during exercise. While exercise MRI has not been previously studied in pediatric HTRs, it has been effectively utilized in children with single ventricle congenital heart disease. The purpose of this study is to fully understand the cardiac adaptations induced by exercise training.
Primary objective: Evaluate the association between exercise MRI cardiac and skeletal muscle measures and cardiorespiratory fitness in pediatric acquired (HTRx) and CHD participants.
Hypothesis: Cardiac adaptations to exercise and skeletal muscle functioning will be positively associated with measured CRF in CHD patients and those post-transplant.
Secondary objective: Evaluate changes in exercise MRI measures of cardiac and skeletal muscle function following a 12-week high-intensity interval training (HIIT) exercise protocol in children with acquired and congenital heart disease.
Hypothesis: a 12-week HIIT intervention will result in improvements in cardiac and skeletal muscle responses to exercise.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 - 18 year olds followed at the Stollery Children's Hospital
- •Heart transplant recipients ≥6 months post-transplant
- •Have a moderate-complex congenital heart disease diagnosis
排除标准
- •Non-English speaking
- •Exercise restricted by the patient's clinical cardiologist
- •Clinical antibody- or cellular-mediated rejection within 3-months of the assessment or during the study period (for HTRs)
- •Previous involvement in a CR or exercise intervention program
- •Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (<20 mmHg) or a systolic BP >200 mmHg, or symptoms of chest pain or syncope
- •Resting arterial saturation <85% or oxygen requirements
- •Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram
- •History of chest pain on exertion; unrepaired/unpalliated CHD
- •Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block or history of (Mobitz II or worse))
- •New York Heart Association class II or worse symptoms
- •Active medical inter-current illness limiting ability to participate
- •Cognitive impairment limiting the communication needed for the exercise MRI
- •Research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing
- •Extracardiac or congenital abnormality limiting the participant's functional ability to exercise
研究组 & 干预措施
Congenital heart disease
Participants aged 10-18 years who have congenital heart disease.
干预措施: Exercise cardiac MRI Assessment (Diagnostic Test)
Congenital heart disease
Participants aged 10-18 years who have congenital heart disease.
干预措施: Cardiopulmonary Exercise Test (Diagnostic Test)
Heart transplant recipient
Participants aged 10-18 years who have recieved a heart transplant.
干预措施: Exercise cardiac MRI Assessment (Diagnostic Test)
Heart transplant recipient
Participants aged 10-18 years who have recieved a heart transplant.
干预措施: Cardiopulmonary Exercise Test (Diagnostic Test)
结局指标
主要结局
MRI assessment of cardiac structure at rest
时间窗: Baseline
Participants will undergo a standard cardiac MRI using a Siemens MAGNETOM Prisma 3.0T CMR (Siemens Healthineers, Erlangen, Germany) for the assessment of resting ventricular structure.
MRI assessment of cardiac function at rest
时间窗: Baseline
Participants will undergo a standard cardiac MRI using a Siemens MAGNETOM Prisma 3.0T CMR (Siemens Healthineers, Erlangen, Germany) for the assessment of resting ventricular function.
Cardioplumonary Exercise Test
时间窗: Baseline
Participants will undergo a cardiopulmonary exercise test using a cycle ergometer to assess VO2peak.
Maximal exercise MRI assessment of cardiac structure
时间窗: Baseline
Participants will undergo an exercise cardiac MRI assessment using an MRI-compatible stepping ergometer (Cardio Step Module, Ergospect) to assess cardiac output.
次要结局
未报告次要终点