Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-09 @ 11:02 AM
Study NCT ID:
NCT00699361
Status:
WITHDRAWN
Last Update Posted:
2014-02-11
First Post:
2008-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study withdrawn for financial issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-10', 'studyFirstSubmitDate': '2008-06-13', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pantoprazole', 'congestive heart failure'], 'conditions': ['Congestive Heart Failure']}, 'referencesModule': {'references': [{'pmid': '17576869', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Only patients older than 18 years. Range 18 to 80 years\n2. Only cooperative patients\n3. Only patients with a need for a coronary angiography, independently from our study\n4. Only patients with a left ventricular ejection fraction as demanded in the study protocol\n5. Only patients with clinical symptoms of congestive heart failure, corresponding to New York Heart Association stage NYHA II or III\n6. Only patients without oral or i.v. application of a proton pump inhibitor up to 48 hours prior to the study catheterization\n\nExclusion Criteria:\n\n1. Manifest or severe accompanying diseases, despite of diabetes mellitus\n2. Intravascular or oral application of proton pump inhibitors within the last 48 hours\n3. Intake of Metformin within the last 24 hours\n4. Status post heart transplant\n5. Pregnancy\n6. Known intolerance of pantoprazole\n7. severe side effects of the tested substance pantoprazole, as well as pharmacokinetic interactions through CYP isoenzymes\n8. 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\n9. Participation in a other clinical trial'}, 'identificationModule': {'nctId': 'NCT00699361', 'briefTitle': 'Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Influence of Pantoprazole on Human Myocardial Contractility at Patients With Congestive Heart Failure', 'orgStudyIdInfo': {'id': 'panto001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Measurement before Pantoprazole application', 'interventionNames': ['Drug: Pantoprazole']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Measurements after Pantoprazole application', 'interventionNames': ['Drug: Pantoprazole']}], 'interventions': [{'name': 'Pantoprazole', 'type': 'DRUG', 'otherNames': ['Protonix'], 'description': 'Pantoprazole 160 mg I.V.', 'armGroupLabels': ['1']}, {'name': 'Pantoprazole', 'type': 'DRUG', 'otherNames': ['Protonix'], 'description': 'Pantoprazole 160 mg intravenously (IV)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Johann Wolfgang Goethe University Hospitals, Department of Cardiology', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Volker Schächinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johann Wolfgang Goethe University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Volker Schächinger, MD', 'oldOrganization': 'Johann Wolfgang Goethe University Hospitals'}}}}