Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure - Full Text View

Sponsor:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00699361

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 III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

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 ]

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
1: Experimental Measurement before Pantoprazole application	Drug: Pantoprazole Pantoprazole 160 mg I.V.
2: Experimental Measurements after Pantoprazole application	Drug: Pantoprazole Pantoprazole 160 mg intravenously (IV)

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699361

Contacts

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

Locations

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

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:

Volker Schächinger, MD

Johann Wolfgang Goethe University Hospitals

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.

Responsible Party:	Johann Wolfgang Goethe University Hospitals ( Volker Schächinger, MD )
Study ID Numbers:	panto001
Study First Received:	June 13, 2008
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00699361 History of Changes
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
Therapeutic Uses
Pantoprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2010