Effects of Changes in Fluid Status on Right Ventricular Volumes and Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Postload volume status
研究概览
简要总结
The purpose of this study is to evaluate the correlation between fluid volume status and right ventricular volume and function, in those with free pulmonary valve insufficiency after Tetralogy of Fallot (TOF) repair.
详细描述
The purpose of this study is to measure the changes in Right Ventricular size and function with changes in preload, using cardiovascular magnetic resonance (CMR). Based on an intensive research and clinical observations the investigators hypothesize that changes in volume status cause a statistically significant difference in the Cardiovascular magnetic resonance (CMR) measured RV End Diastolic Volume (EDV), end-systolic volume (ESV), ejection fraction (EF) and pulmonary regurgitation (PR). The investigator hypothesizes that smaller changes will occur in left ventricular LV EDV, ESV, and EF.
- To establish a correlation between the changes in preload volume status and RV size and function in patients with free pulmonary insufficiency (PI) after TOF repair using CMRI.
- To assess the effects of preload status on the measured severity of pulmonary regurgitation (PR).
- To assess the effects of preload status on the left ventricular (LV) size
This study will be conducted in compliance with this protocol, good clinical practice and the applicable regulatory requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •TOF patients who have had repair using a transannular patch.
- •Patients that present with free pulmonary insufficiency.
- •Are older than 18 years.
排除标准
- •Patients who have lesions predisposing to chronic volume overload (i.e. patients with significant residual postoperative ventricular septal defects (VSD), or large aorto-pulmonary collaterals or more than moderate tricuspid insufficiency) since all these hemodynamic conditions can influence the late function of the right ventricle and potentially affect the response of the right side of the heart in changes in volume status
- •Patients who had a valve sparing TOF repair and have less than free pulmonary insufficiency.
- •Patients who have significant residual right-sided obstruction (i.e. patients who have residual RVOT obstruction or significant residual branch pulmonary artery stenosis), as it is shown that residual pulmonary stenosis may protect from RV dilation and from deterioration of the RV function.
- •Patients who cannot be reconstructed with a transannular patch and/or require a right ventricle to pulmonary artery homograft for reconstruction including:
- •pulmonary atresia and VSD
- •patients with anomalous coronary crossing the right ventricular outflow tract (RVOT) and
- •patients with TOF-absent pulmonary valve syndrome.
- •Patients with renal failure and renal insufficiency
- •Patients with uncompensated heart failure
- •Cancer patients
- •Latex allergic patients
- •Patients with diabetes
- •Pregnant females
- •Individuals who lack consent capacity
研究组 & 干预措施
Study Group
Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
干预措施: Electrocardiogram (Procedure)
Study Group
Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
干预措施: Chest X-ray (Procedure)
Study Group
Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
干预措施: Cardiac Magnetic Resonance Imaging (CMRI) (Procedure)
Study Group
Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
干预措施: Central venous line placement (Procedure)
Study Group
Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
干预措施: Fluid administration (Procedure)
Study Group
Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
干预措施: Blood Draw (Procedure)
Study Group
Procedures include:
Two Cardiac Magnetic Resonance Imaging (CMRIs) A central venous line placement, A chest X-ray Electrocardiogram (ECG) Fluid administration Blood draw Pregnancy test
干预措施: Pregnancy test (Procedure)
结局指标
主要结局
Postload volume status
时间窗: 24 months
The following will be measured to define the postload volume status: Left and right ventricle end diastolic volume (milliliters \[ml\]); Ejection fraction (%); pulmonary regurgitation
次要结局
未报告次要终点