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

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).

Study Type: Interventional

Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Pantoprazole
  • Pantoprazole 160 mg I.V.
• Drug: Pantoprazole
  • Pantoprazole 160 mg intravenously (IV)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Measurement before Pantoprazole application
• Experimental: 2
  • Measurements after Pantoprazole application

Primary 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
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johann Wolfgang Goethe University Hospitals

Overall Clinical Trial Officials and Contacts

Volker Schächinger, MD Principal Investigator Johann Wolfgang Goethe University Hospitals  

Overall Contact: Volker Schächinger, MD 49-696-3015-579 schaechinger@em.uni-frankfurt.de

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699361

Study ID Number: panto001

ClinicalTrials.gov Identifier: NCT00699361

Health Authority: Germany: Ethics Commission