Placebo-Controlled Crossover Study for the Investigation of the Effect of Pantoprazole on Cardiac Contractility
Information source: Herzzentrum Goettingen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Pantoprazole (Drug); Placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Herzzentrum Goettingen Official(s) and/or principal investigator(s):
Gerd Hasenfuss, Prof. Dr., Principal Investigator, Affiliation: Herzzentrum Goettingen
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.
Clinical Details
Official title: Heart Issues of PantoPrazOle (HIPPO)
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Echocardiographic ejection fraction
Secondary outcome: Cardiac index
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dept. of Cardiology and Pneumology; Herzzentrum Goettingen, Goettingen 37099, Germany
Additional Information
Herzzentrum Goettingen - Heart Center of Goettingen
Starting date: May 2005
Ending date: November 2006
Last updated: February 9, 2008
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