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临床试验/NCT00402376
NCT00402376终止4 期

Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure

University Hospital, Strasbourg, France4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年4月1日最近更新:
适应症
相关药物

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

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.

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other

研究点 (4)

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