Autonomic Cardiovascular Control After Heart Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acute rejections
研究概览
简要总结
The purpose of this prospective study is to investigate denervation (ie. surgical cutting of autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant recipients. More specifically, we focus on:
- The physiological consequences of denervation, in particular its consequences for clinical symptoms, orthostatic tolerance (ie. the ability to stand upright) and exercise capacity. We hypothesize that denervation has negative consequences for all these factors.
- The pathological consequences of denervation and reinnervation, in particular its association to acute rejection and coronary artery disease (cardiac allograft vasculopathy, CAV). We hypothesize that reinnervation protects against acute rejection and development of CAV
- Donor and recipient factors associated with the reinnervation process. We hypothesize that characteristics of the surgical procedure (such as aorta cross-clamp time) as well as the rehabilitation process of the recipient (such as physical activity) impacts on the reinnervation process.
详细描述
Heart transplantation is annually offered to more than 3500 patients worldwide. In Norway, the number is approximately 30/year, and all transplants are carried out at one single hospital (Oslo University Hospital, Rikshospitalet).
Normally, the heart function is intimately controlled by the autonomic nervous system (ANS), but all nervous connections are lost during the surgical transplantation procedure, and the transplanted heart thus becomes denervated. In time, regrowth of nerves may cause partial reinnervation of the new heart.
Some evidence suggests that reinnervation improves exercise capacity and reduces episodes of acute rejections and the development of cardiac allograft vasculopathy. The purpose of this study is further to investigate the changes over time with respect to all parts of the autonomic nervous system (the sympathetic, parasympathetic and sensoric part), and the associated physiological and pathological consequences.
The study may provide knowledge which ultimately could help us improve health and quality of live for heart transplant recipients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acute rejections
时间窗: 1 year
The frequency of acute rejections episodes and time to first rejection (combined time/event outcome), as assessed by analyses of heart biopsy specimens
Cardiac allograft vasculopathy
时间窗: 1 year
Indications of cardiac allograft vasculopathy (CAV), assessed by intravascular ultrasound (IVUS) during coronary catheterization.
次要结局
- Ambulant blood pressure recording(1, 2 and 3 years)
- Cardiac catheterization(1, 2 and 3 years)
- Acute rejections(2 and 3 years)
- Activity recordings(6 months, 1, 2 and 3 years)
- Clinical symptoms(6 months, 1, 2 and 3 years)
- Cardiac allograft vasculopathy(3 years)
- Hormonal levels(6 months, 1, 2 and 3 years)
- Pain threshold(6 months, 1, 2 and 3 years)
- Autonomic cardiovascular responses(6 months, 1, 2 and 3 years)
- Exercise capacity(1, 2 and 3 years)
- General immune activity(6 months, 1, 2 and 3 years)
- MetaIodoBenzylGuanidin-scan(1 and 3 years)
- Echocardiographic indices(1, 2 and 3 years)
研究者
Vegard Bruun Wyller
MD, PhD Dept of Pediatrics, Oslo University Hospital, Norway
Oslo University Hospital