Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Mitochondrial function
研究概览
简要总结
Cardiac function may improve in patients with end-stage heart failure who receive long-term support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be sufficient in some cases to allow explantation of the VAD. However, some questions continue to await definitive answers. This study is designed to assess the myocardial recovery under VAD support with optimal pharmacological therapy (high doses [group I] of statins, beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses [group II]).
The study is a randomized, single-blind trial performed at the Department of Cardiac Surgery, University of Strasbourg, France. Twenty patients with end-stage heart failure who will be supported by VAD (Thoratec paracorporeal device) as a bridge to heart transplantation will be included. Reverse left ventricular remodeling and myocardial function will be studied by: echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal function, and inflammatory response. Myocardial biopsies will be obtained at the time of VAD implantation and heart transplantation. The follow-up will be performed every 4 weeks during the VAD support period. The hypothesis of this trial is that reverse left ventricular remodeling and myocardial function will improve under optimal medical therapy especially by a high dose statin.
详细描述
Evaluation of Myocardial Improvement (Reverse Left Ventricular Remodeling, Mitochondrial Respiratory Function) in Patients Supported by Ventricular Assist Device Under Optimal Pharmacological Therapy
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
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
- •Patients with end-stage heart failure refractory to medical therapy and who fulfill criteria for VAD implantation as a bridge to heart transplantation
- •Age > 18
排除标准
- •Myocarditis
结局指标
主要结局
Mitochondrial function
时间窗: at implantation and explantation of VAD
次要结局
- Inflammation: IL-6; IL-8; IL-10, IL-18, TNF-α
- Exercise testing : stress echocardiography, peak oxygen consumption
- Hormonal cardiac function: ANP, BNP
- Ventricular remodelling: echocardiography
- All those parameters will be measured in the post-operative course and every 4 weeks during all the VAD support period.
