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

Primary Purpose

Congestive Heart Failure

Status
Withdrawn
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pantoprazole
Pantoprazole
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Pantoprazole, congestive heart failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johann Wolfgang Goethe University Hospitals, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Measurement before Pantoprazole application

Measurements after Pantoprazole application

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2008
Last Updated
February 10, 2014
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00699361
Brief Title
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

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn for financial issues
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Pantoprazole, congestive heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Measurement before Pantoprazole application
Arm Title
2
Arm Type
Experimental
Arm Description
Measurements after Pantoprazole application
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Protonix
Intervention Description
Pantoprazole 160 mg I.V.
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Protonix
Intervention Description
Pantoprazole 160 mg intravenously (IV)
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Schächinger, MD
Organizational Affiliation
Johann Wolfgang Goethe University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johann Wolfgang Goethe University Hospitals, Department of Cardiology
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17576869
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.
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Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

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