Official Title: “Heart Issues of PantoPrazOle (HIPPO)”

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2006

Context: Recent reports on cardiac side effects of oral proton pump inhibitors have caused an extensive safety review by the U.S. Food and Drug Administration (FDA). Data on cardiac effects of intravenous application are missing.

Objective: To test the effect of a common high dose regimen of pantoprazole on left ventricular function in healthy volunteers.

Design, Setting, and Patients: A randomized placebo-controlled cross-over trial (May 2005 - January 2006) involving 20 healthy volunteers without cardiac disease in the Department of Cardiology and Pneumology, University Medical Center Goettingen, Germany.

Interventions: A common high dose regimen of pantoprazole providing 80 mg given intravenously over 2 minutes followed by 8 mg/h for 1 hour.

Main Outcome Measures: Echocardiographic ejection fraction (EF), cardiac output and cardiac index.

Intervention(s) in this Clinical Trial

• Drug: Pantoprazole
  • 80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes
• Drug: Placebo
  • Identical infusion manner like experimental arm

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Pantoprazole IV
• Placebo Comparator: B
  • NaCl 0.9% IV

Primary Measures

• Echocardiographic ejection fraction
  • Time Frame: 60 min
    Safety Issue?: Yes

Secondary Measures

• Cardiac index
  • Time Frame: 60 min
    Safety Issue?: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Herzzentrum Goettingen

Overall Clinical Trial Officials and Contacts

Gerd Hasenfuss, Prof. Dr. Principal Investigator Herzzentrum Goettingen  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00600041

Study ID Number: HIPPO1-2004-11-01

ClinicalTrials.gov Identifier: NCT00600041

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Herzzentrum Goettingen - Heart Center of Goettingen