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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699361
Recruitment Status : Withdrawn (Study withdrawn for financial issues)
First Posted : June 18, 2008
Last Update Posted : February 11, 2014
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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).

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Pantoprazole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699361


Locations
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Germany
Johann Wolfgang Goethe University Hospitals, Department of Cardiology
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Volker Schächinger, MD Johann Wolfgang Goethe University Hospital
Publications:
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Responsible Party: Volker Schächinger, MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00699361    
Other Study ID Numbers: panto001
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: June 2008
Keywords provided by Johann Wolfgang Goethe University Hospital:
Pantoprazole
congestive heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action