Clinical trial NCT00699361: Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure
Official title: Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Congestive Heart Failure
Keywords: Pantoprazole
congestive heart failure
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe University Hospitals, Department of Cardiology
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Volker Schächinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.