Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Serum TMAO
研究概览
简要总结
Despite medical and surgical advances, long-term survival in liver transplant (LT) recipients is compromised by an increased risk of cardiovascular disease (CVD) after transplant, the mechanisms of which are still not fully understood. TMAO is an attractive therapeutic target to improve vascular health and diastolic function toward preventing CVD in LT patients. Therefore, the purpose of this study is to better understand the role of TMAO in cardiovascular dysfunction patients with chronic kidney disease.
详细描述
Despite medical and surgical advances, long-term survival in liver transplant (LT) recipients is compromised by an increased risk of cardiovascular disease (CVD) after transplant, the mechanisms of which are still not fully understood. Following LT, patients have an increased incidence of atherosclerotic CVD. Notably, atherosclerotic CVD is an established risk factor for diastolic dysfunction and incident heart failure with preserved ejection fraction (HFpEF). There is a critical need to better understand the biological mechanisms of LT related vascular dysfunction and establish targeted interventions that will reduce the risk of CVD in this patient population. In the general population, there is strong epidemiological evidence linking high TMAO levels with atherosclerotic CVD and heart failure, and that it can modulated rapidly by diet within two weeks. Therefore, the purpose of this study is to better understand the role of TMAO in cardiovascular dysfunction patients with chronic kidney disease.
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 (Outcomes Assessor)
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
- •Aged > 18 years
- •Speak and understand English
- •Have received and LT
排除标准
- •Acute cellular or chronic rejection within 3 months
- •Post-LT liver or non-liver related malignancy
- •Active viral hepatitis (B or C) or autoimmune hepatitis
- •Untreated biliary strictures or vascular complications (e.g. hepatic artery thrombosis)
- •Poorly controlled diabetes (HbA1c >8.5%)
- •Relapse of alcohol use after LT
- •Follow a vegetarian or vegan diet
- •Current pregnancy
- •Unable to provide informed consent
结局指标
主要结局
Serum TMAO
时间窗: Change from baseline at four weeks
Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR)
次要结局
- Microvascular function change(Change from baseline at four weeks)
- Quality of life changes(Change from baseline at four weeks)
- Conduit artery endothelial function changes(Change from baseline at four weeks)
- Arterial hemodynamics changes(Change from baseline at four weeks)
- Diastolic Function change(Change from baseline at four weeks)
- Frailty outcome hanges(Change from baseline at four weeks)