Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Aim of our clinical study is to examine, whether proton pump inhibitors have an influence on myocardial contraction of human myocard and we want to ascertain the amount of influence of a H+/K+ ATPase on myocardial contraction.
研究概览
简要总结
Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999).
详细描述
Recently literature revealed facts, that show H+/K+ ATPase expression is not limited tot he stomach. H+/K+ ATPase was also found in smooth muscle cells and in other tissues (McCabe, R.D. et al., Am J Physiol. 1992). For myocard a localisation is only proven for rats yet (Beisvag, V. et al., Acta Physiol Scand. 2003). Moreover biochemical hints lead us to a highly probability of a myocardial H+/K+ ATPase (Nagashima, R. et al., Jpn Heart J. 1999). Aim of our clinical study is to examine, whether proton pump inhibitors have an influence on myocardial contraction of human myocard and we want to ascertain the amount of influence of a H+/K+ ATPase on myocardial contraction. Therefore the mechanism of a putative inhibition by proton pump inhibitors is at our focus. These findings will be of major credit regarding treatment of patients with congestive heart failure with common proton pump inhibitors. We want to find out, whether this intake may have a negative inotropic effect on the heart failure myocard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients older than 18 years. Range 18 to 80 years
- •Only cooperative patients
- •Only patients with a need for a coronary angiography, independently from our study
- •Only patients with a left ventricular ejection fraction as demanded in the study protocol
- •Only patients with clinical symptoms of congestive heart failure, corresponding to New York Heart Association stage NYHA II or III
- •Only patients without oral or i.v. application of a proton pump inhibitor up to 48 hours prior to the study catheterization
排除标准
- •Manifest or severe accompanying diseases, despite of diabetes mellitus
- •Intravascular or oral application of proton pump inhibitors within the last 48 hours
- •Intake of Metformin within the last 24 hours
- •Status post heart transplant
- •Known intolerance of pantoprazole
- •severe side effects of the tested substance pantoprazole, as well as pharmacokinetic interactions through CYP isoenzymes
- •Existance of side effects as given in the pantoprazole drug information, among others disturbances of blood- and lymphatic system, leukopenia, thrombopenia, affections of gastrointestinal tract, nerve system affections, psychiatric affections, renal or bladder affections
- •Participation in a other clinical trial
研究组 & 干预措施
2
Measurements after Pantoprazole application
干预措施: Pantoprazole (Drug)
1
Measurement before Pantoprazole application
干预措施: Pantoprazole (Drug)
结局指标
主要结局
Aim of our clinical study is to examine, whether proton pump inhibitors have an influence on myocardial contraction of human myocard and we want to ascertain the amount of influence of a H+/K+ ATPase on myocardial contraction.
时间窗: 6 months
次要结局
未报告次要终点