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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00600041
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : March 24, 2009
University of Göttingen
Gastroenterology and Endocrinology, University Medicine of Goettingen
Medical Statistics, University Medicine of Goettingen
Information provided by:
Herzzentrum Goettingen

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Pantoprazole Drug: Placebo Phase 1

Detailed Description:

Purpose: Reports on cardiac problems with oral proton pump inhibitors have caused extensive safety reviews by the U.S. Food and Drug Administration. We provide additional data on acute cardiac effects of an intravenous application.

Methods: Echocardiography was performed in 18 healthy volunteers after administration of a common high dose regimen of pantoprazole (80 mg IV bolus followed by 8 mg/h for 1h) or placebo. Design: Randomized, double-blind, placebo-controlled crossover trial.

Results: EF [%, means+/-S.E.] in the treatment group (placebo group) was 60.7+/-1.1 (61.2+/-1.7) at baseline, and 62.6+/-1.1 (62.1+/-1.9), 64.7+/-1.6 (63.5+/-1.3), 62.6+/-1.6 (61.0+/-1.6) and 63.0+/-1.4 (61.8+/-1.5) at 7.5, 15, 30 and 60 min after bolus application, respectively (p = n.s.). Similarly, no significant changes were found for cardiac output, cardiac index, blood pressure, and heart rate. In contrast, gastric pH that was used as a treatment control was significantly increased 60 min after application of pantoprazole as compared to baseline and to placebo.

Conclusions: Pantoprazole for injection is safe in healthy subjects with respect to cardiac contractile function. However, in view of recent reports of negative inotropy of the drug further studies in heart failure patients are required.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Heart Issues of PantoPrazOle (HIPPO)
Study Start Date : May 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Pantoprazole IV
Drug: Pantoprazole
80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes
Other Names:
  • Pantozol i.v.
  • Protonix I.V.

Placebo Comparator: B
NaCl 0.9% IV
Drug: Placebo
Identical infusion manner like experimental arm
Other Name: NaCl 0.9%

Primary Outcome Measures :
  1. Echocardiographic ejection fraction [ Time Frame: 60 min ]

Secondary Outcome Measures :
  1. Cardiac index [ Time Frame: 60 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00600041

Dept. of Cardiology and Pneumology; Herzzentrum Goettingen
Goettingen, Germany, 37099
Sponsors and Collaborators
Herzzentrum Goettingen
University of Göttingen
Gastroenterology and Endocrinology, University Medicine of Goettingen
Medical Statistics, University Medicine of Goettingen
Principal Investigator: Gerd Hasenfuss, Prof. Dr. Herzzentrum Goettingen

Additional Information:
Publications of Results:
Responsible Party: Gerd Hasenfuss/Prof. Dr., Head of dept. of Cardiology and Pneumology, Herzzentrum Goettingen, Dept. of Cardiology and Pneumology Identifier: NCT00600041     History of Changes
Other Study ID Numbers: HIPPO1-2004-11-01
2004-004355-18 (EudraCT)
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: March 24, 2009
Last Verified: February 2008

Keywords provided by Herzzentrum Goettingen:
Proton Pump Inhibitors
Cardiac Output
adverse effects

Additional relevant MeSH terms:
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action