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

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).
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
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
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)	Experimental: 1 Measurement before Pantoprazole application Experimental: 2 Measurements after Pantoprazole application

Recruitment Information[ + expand ][ + ]

Recruitment Status	Withdrawn
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
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

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