Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: Pantoprazole
* Drug: Pantoprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Pregnancy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Measurement before Pantoprazole application | Drug: Pantoprazole<br>* Pantoprazole 160 mg I.V.<br>* Other names: Protonix;|
| Experimental: 2<br>Measurements after Pantoprazole application | Drug: Pantoprazole<br>* Pantoprazole 160 mg intravenously (IV)<br>* Other names: Protonix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pantoprazole, congestive heart failure