Auswirkungen von Pantoprazol auf die myokardiale Kontraktilität bei Patienten mit Herzinsuffizienz - influence of pantoprazole on human myocardial contractility at patients with congestive heart failure

Conditions: 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).

Registration Number: EUCTR2008-002278-37-DE

Lead Sponsor: Johann Wolfgang Goethe Universität

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

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 catherization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: ;Primary end point(s): Primary end point is negative influence of proton pump inhibitors on hemodynamics in sense of negative inotropic effects on human myocard.

Secondary Outcome Measures