Placebo-Controlled Crossover Study for the Investigation of the Effect of Pantoprazole on Cardiac Contractility

NCT00600041 | Completed Phase 1

• 2 other identifiers: HIPPO1-2004-11-012004-004355-18 (EudraCT)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, negative inotropy of pantoprazole has been shown in isolated human myocardium. This study was designed to test the clinical relevance of this finding in healthy volunteers by measuring left ventricular function during infusion of a common intravenous high dose regimen of pantoprazole.

Conditions

Healthy

Keywords

Proton Pump Inhibitors; pantoprazole; Cardiac Output; Echocardiography; adverse effects

Outcome Measures

Primary Outcomes (1)

• Echocardiographic ejection fraction

  60 min

Secondary Outcomes (1)

• Cardiac index

  60 min

Study Arms (2)

A

EXPERIMENTAL

Pantoprazole IV

Drug: Pantoprazole

B

PLACEBO COMPARATOR

NaCl 0.9% IV

Drug: Placebo

Interventions

Pantoprazole DRUG

80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes

Also known as: Pantozol i.v., Protonix I.V.

A

Placebo DRUG

Identical infusion manner like experimental arm

Also known as: NaCl 0.9%

B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \> 18 or \< 40 years
• No signs of overt heart failure
• Echocardiographic ejection fraction \>= 55%
• Body Mass Index 20 - 25 kg/m²
• Excellent sonographic conditions
• Non-smoker
• Informed consent

You may not qualify if:

• History of cardiac disease
• History of other relevant pre-existing illness
• Pathologic findings in clinical examinations
• Pathologic echocardiographic findings
• Pathologic ECG findings
• Pathologic laboratory findings
• Pregnancy and lactation
• No or insufficient contraception
• Intolerance of pantoprazole
• Alcohol or drug abuse

Sponsors & Collaborators

• Herzzentrum Goettingen: lead
• University of Göttingen: collaborator
• Gastroenterology and Endocrinology, University Medicine of Goettingen: collaborator
• Medical Statistics, University Medicine of Goettingen: collaborator

Study Sites (1)

Dept. of Cardiology and Pneumology; Herzzentrum Goettingen

Göttingen, 37099, Germany

Location

Related Publications (1)

• Schillinger W, Hornes N, Teucher N, Sossalla S, Sehrt D, Jung K, Hunlich M, Unsold B, Geiling B, Ramadori G, Hilgers R, Schworer H, Hasenfuss G. Recent in vitro findings of negative inotropy of pantoprazole did not translate into clinically relevant effects on left ventricular function in healthy volunteers. Clin Res Cardiol. 2009 Jun;98(6):391-9. doi: 10.1007/s00392-009-0012-6. Epub 2009 Mar 20.

  PMID: 19301059 RESULT

MeSH Terms

Interventions

Pantoprazole; Sodium Chloride

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gerd Hasenfuss, Prof. Dr.

  Herzzentrum Goettingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: May 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 24, 2009

Record last verified: 2008-02

Locations

DE (1)