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临床试验/NCT02663115
NCT02663115
已完成
不适用

Influence of Severe Heart Failure to Function and Molecular Biological Parameters of Catabolism in the Human Diaphragm and Peripheral Skeletal Muscle

Norman Mangner1 个研究点 分布在 1 个国家目标入组 44 人2016年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Heart Failure
发起方
Norman Mangner
入组人数
44
试验地点
1
主要终点
Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)
状态
已完成
最后更新
7年前

概览

简要总结

Project aim is to quantify the influence of a severe therapy-refractory heart failure caused by ischemic or dilative myocardiopathy on the function of the diaphragm, its molecular biological parameters and on the M. vastus lateralis. The control group consists of patients with coronary artery disease (CAD) and normal left ventricular ejection fraction indicated for coronary artery bypass graft surgery (CABG) Differences in the geneses of heart failure (ischemic vs. dilative cardiomyopathy) will be evaluated during analysis. The ubiquitin-proteasome signaling pathway is considered as a central issue for the mechanism of the analyses muscle catabolism.

注册库
clinicaltrials.gov
开始日期
2016年1月
结束日期
2018年3月
最后更新
7年前
研究类型
Observational
性别
All

研究者

发起方
Norman Mangner
责任方
Sponsor Investigator
主要研究者

Norman Mangner

Dr. med. Norman Mangner

Heart Center Leipzig - University Hospital

入排标准

入选标准

  • inclusion criteria Group A:
  • age 40 - 70 years
  • Restricted left ventricular pump function left ventricular ejection fraction (LVEF) \> 35% on the basis of ischemic cardiomyopathy (ICM) and restricted resting cardiac output (CI\> 2.4 L / min / m²)
  • or restricted maximal oxygen uptake (VO2max\> 17 ml / min / m²)
  • Duration of heart failure\> 1 year
  • Maximum of individual heart failure therapy
  • Heart team decision to LVAD Implantation
  • inclusion criteria Group B:
  • age 40 - 70 years
  • Restricted left ventricular pump function (LVEF) \> 35% on the basis of dilatative cardiomyopathy (DCM) and restricted resting cardiac output (CI\> 2.4 L / min / m²)

排除标准

  • Mechanical ventilation within the last 3 months
  • Forced Expiratory Pressure (FEV1) \<70% of the norm and / or therapy with α antagonists, β-mimetics or inhaled corticosteroids for the treatment of a lung disease
  • Pulmonary fibrosis
  • elevated diaphragm in the ultrasound or X-ray diagnosis or known paresis of the phrenic nerve
  • chronic kidney disease (CKD) stage 4 and 5, i.e. glomerular filtration rate (GFR) \<30ml / min / 1.73m and / or dialysis
  • Acute renal failure
  • Treatment with immunosuppressive agents
  • Hepatic insufficiency Child-Pugh B and C
  • Higher grade ventricular arrhythmias (Lown IV b)
  • Acute myocardial infarction (less than three months)

结局指标

主要结局

Expression of catabolic E3 ligase Muscle ring finger 1 (MuRF1)

时间窗: at the time of index procedure (biopsy)

次要结局

  • in vitro measurement of the muscle protein - poly ubiquitination of Proteins(at the time of index procedure (biopsy))
  • in vitro measurement of the muscle protein - fiber typing in the muscle samples(at the time of index procedure (biopsy))
  • in vitro measurement of the force development of skinned muscle fibers(at the time of index procedure (biopsy))
  • in vitro measurement of the muscle protein - the proteasome activity(at the time of index procedure (biopsy))

研究点 (1)

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