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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00699361
• Other study ID #: panto001
• Status: Withdrawn
• Phase: Phase 3
• First received: June 13, 2008
• Last updated: February 10, 2014
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2008
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University Hospitals, Department of Cardiology	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes