NCT00699361

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 11, 2014

Status Verified

June 1, 2008

Enrollment Period

4 months

First QC Date

June 13, 2008

Last Update Submit

February 10, 2014

Conditions

Congestive Heart Failure

Keywords

Pantoprazolecongestive heart failure

Outcome Measures

Primary Outcomes (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.

    6 months

Study Arms (2)

1

EXPERIMENTAL

Measurement before Pantoprazole application

Drug: Pantoprazole

2

EXPERIMENTAL

Measurements after Pantoprazole application

Drug: Pantoprazole

Interventions

PantoprazoleDRUG

Pantoprazole 160 mg I.V.

Also known as: Protonix
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe University Hospitals, Department of Cardiology

Frankfurt am Main, 60590, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17576869BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Volker Schächinger, MD

    Johann Wolfgang Goethe University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 11, 2014

Record last verified: 2008-06

Locations

DE(1)