Influence of Pantoprazole on Human Myocardial Contractili... | NCT00699361

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

NCT00699361

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Withdrawn

Last Update Posted

Feb 11, 2014Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Congestive Heart Failure

Interventions

Pantoprazole
Pantoprazole

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study withdrawn for financial issues

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 17, 2008

First Posted Date

Jun 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2014

Last Update Posted Date

Feb 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Measurement before Pantoprazole application	Drug: Pantoprazole
2	Experimental	Measurements after Pantoprazole application	Drug: Pantoprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pantoprazole	Drug	Pantoprazole 160 mg I.V.	1	Protonix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Volker Schächinger, MD	Johann Wolfgang Goethe University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johann Wolfgang Goethe University Hospitals, Department of Cardiology		Frankfurt am Main		60590	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17576869	Background	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals