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

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00699361
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 0

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Drug: Pantoprazole; Drug: Pantoprazole	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Measurement before Pantoprazole application	Drug: Pantoprazole; Pantoprazole 160 mg I.V.; Other Names: Protonix
Experimental: 2 Measurements after Pantoprazole application	Drug: Pantoprazole; Pantoprazole 160 mg intravenously (IV); Other Names: Protonix

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johann Wolfgang Goethe University Hospitals, Department of Cardiology	Frankfurt am Main		Germany	60590

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

• Principal Investigator: Volker Schächinger, MD, Johann Wolfgang Goethe University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Schillinger W, Teucher N, Sossalla S, Kettlewell S, Werner C, Raddatz D, Elgner A, Tenderich G, Pieske B, Ramadori G, Schöndube FA, Kögler H, Kockskämper J, Maier LS, Schwörer H, Smith GL, Hasenfuss G. Negative inotropy of the gastric proton pump inhibitor pantoprazole in myocardium from humans and rabbits: evaluation of mechanisms. Circulation. 2007 Jul 3;116(1):57-66. Epub 2007 Jun 18.

• ClinicalTrials.gov Identifier: NCT00699361
• Other Study ID Numbers: panto001
• First Posted: Jun 18, 2008
• Last Update Posted: Feb 11, 2014
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Pantoprazole; congestive heart failure
• Additional relevant MeSH terms: Heart Failure; Pantoprazole

Study Results

No Results Posted as of Feb 11, 2014