Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure
Recruitment status was Recruiting
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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 | Intervention | Phase |
|---|---|---|
|
Congestive Heart Failure |
Drug: Pantoprazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure |
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Measurement before Pantoprazole application
|
Drug: Pantoprazole
Pantoprazole 160 mg I.V.
Other Name: Protonix
|
|
Experimental: 2
Measurements after Pantoprazole application
|
Drug: Pantoprazole
Pantoprazole 160 mg intravenously (IV)
Other Name: Protonix
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Volker Schächinger, MD | 49-696-3015-579 | schaechinger@em.uni-frankfurt.de |
| Contact: Henrik Fox, MD | 49-696-3014-360 | henrik.fox@kgu.de |
| Germany | |
| Johann Wolfgang Goethe University Hospitals, Department of Cardiology | Recruiting |
| Frankfurt am Main, Germany, 60590 | |
| Contact: Volker Schächinger, MD 49-696-3015-579 schaechinger@em.uni-frankfurt.de | |
| Contact: Henrik Fox, MD 49-696-3014-360 henrik.fox@kgu.de | |
| Principal Investigator: Volker Schächinger, MD | |
| Principal Investigator: | Volker Schächinger, MD | Johann Wolfgang Goethe University Hospitals |
More Information
Publications:
| Responsible Party: | Volker Schächinger, MD, Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT00699361 History of Changes |
| Other Study ID Numbers: | panto001 |
| Study First Received: | June 13, 2008 |
| Last Updated: | August 13, 2008 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
Pantoprazole congestive heart failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Pantoprazole Proton Pump Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013