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

NCT ID: NCT00699361

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-12-31

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Measurement before Pantoprazole application

Group Type: EXPERIMENTAL

Pantoprazole

Intervention Type: DRUG

Pantoprazole 160 mg I.V.

2

Measurements after Pantoprazole application

Group Type: EXPERIMENTAL

Pantoprazole

Intervention Type: DRUG

Pantoprazole 160 mg intravenously (IV)

Interventions

Pantoprazole

Pantoprazole 160 mg I.V.

Intervention Type: DRUG

Pantoprazole

Pantoprazole 160 mg intravenously (IV)

Intervention Type: DRUG

Other Intervention Names

Protonix; Protonix

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Johann Wolfgang Goethe University Hospitals

Principal Investigators

Volker Schächinger, MD

Role: PRINCIPAL_INVESTIGATOR

Johann Wolfgang Goethe University Hospital

Locations

Johann Wolfgang Goethe University Hospitals, Department of Cardiology

Frankfurt am Main, , Germany

Countries

Germany

References

Schillinger W, Teucher N, Sossalla S, Kettlewell S, Werner C, Raddatz D, Elgner A, Tenderich G, Pieske B, Ramadori G, Schondube FA, Kogler H, Kockskamper J, Maier LS, Schworer 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. doi: 10.1161/CIRCULATIONAHA.106.666008. Epub 2007 Jun 18.

Reference Type: BACKGROUND

PMID: 17576869 (View on PubMed)

Other Identifiers

panto001

Identifier Type: -

Identifier Source: org_study_id