Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure
Overview[ - collapse ][ - ]
Purpose | 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). |
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Condition | Congestive Heart Failure |
Intervention | Drug: Pantoprazole Drug: Pantoprazole |
Phase | Phase 3 |
Sponsor | Johann Wolfgang Goethe University Hospitals |
Responsible Party | Johann Wolfgang Goethe University Hospitals |
ClinicalTrials.gov Identifier | NCT00699361 |
First Received | June 13, 2008 |
Last Updated | February 10, 2014 |
Last verified | June 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | June 13, 2008 |
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Last Updated Date | February 10, 2014 |
Start Date | August 2008 |
Estimated Primary Completion Date | December 2008 |
Current Primary Outcome Measures | 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. [Time Frame: 6 months] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure |
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Official Title | Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure |
Brief Summary | 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 | 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. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Congestive Heart Failure |
Intervention | Drug: Pantoprazole Pantoprazole 160 mg I.V. Other Names: ProtonixDrug: Pantoprazole Pantoprazole 160 mg intravenously (IV) Other Names: Protonix |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Withdrawn |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | December 2008 |
Estimated Primary Completion Date | December 2008 |
Eligibility Criteria | Inclusion Criteria: 1. Only patients older than 18 years. Range 18 to 80 years 2. Only cooperative patients 3. Only patients with a need for a coronary angiography, independently from our study 4. Only patients with a left ventricular ejection fraction as demanded in the study protocol 5. Only patients with clinical symptoms of congestive heart failure, corresponding to New York Heart Association stage NYHA II or III 6. Only patients without oral or i.v. application of a proton pump inhibitor up to 48 hours prior to the study catheterization Exclusion Criteria: 1. Manifest or severe accompanying diseases, despite of diabetes mellitus 2. Intravascular or oral application of proton pump inhibitors within the last 48 hours 3. Intake of Metformin within the last 24 hours 4. Status post heart transplant 5. Pregnancy 6. Known intolerance of pantoprazole 7. severe side effects of the tested substance pantoprazole, as well as pharmacokinetic interactions through CYP isoenzymes 8. 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 9. Participation in a other clinical trial |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Germany |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00699361 |
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Other Study ID Numbers | panto001 |
Has Data Monitoring Committee | Yes |
Information Provided By | Johann Wolfgang Goethe University Hospitals |
Study Sponsor | Johann Wolfgang Goethe University Hospitals |
Collaborators | Not Provided |
Investigators | Principal Investigator: Volker Schächinger, MD Johann Wolfgang Goethe University Hospitals |
Verification Date | June 2008 |
Locations[ + expand ][ + ]
Johann Wolfgang Goethe University Hospitals, Department of Cardiology | Frankfurt am Main, Germany, 60590 |
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