Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
(Study withdrawn for financial issues)
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00699361
First received: June 13, 2008
Last updated: February 10, 2014
Last verified: June 2008
  Purpose

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).


Condition Intervention Phase
Congestive Heart Failure
Drug: Pantoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Measurement before Pantoprazole application
Drug: Pantoprazole
Pantoprazole 160 mg I.V.
Other Name: Protonix
Experimental: 2
Measurements after Pantoprazole application
Drug: Pantoprazole
Pantoprazole 160 mg intravenously (IV)
Other Name: Protonix

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699361

Locations
Germany
Johann Wolfgang Goethe University Hospitals, Department of Cardiology
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Volker Schächinger, MD Johann Wolfgang Goethe University Hospitals
  More Information

Publications:
Responsible Party: Volker Schächinger, MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00699361     History of Changes
Other Study ID Numbers: panto001
Study First Received: June 13, 2008
Last Updated: February 10, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Pantoprazole
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Pantoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014