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

This study has been completed.
Sponsor:
Collaborators:
Thoracic, Cardiac and Vascular Surgery, University Medicine of Goettingen
Gastroenterology and Endocrinology, University Medicine of Goettingen
Medical Statistics, University Medicine of Goettingen
Information provided by:
Herzzentrum Goettingen
ClinicalTrials.gov Identifier:
NCT00600041
First received: January 11, 2008
Last updated: March 22, 2009
Last verified: February 2008
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Pantoprazole
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Heart Issues of PantoPrazOle (HIPPO)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herzzentrum Goettingen:

Primary Outcome Measures:
  • Echocardiographic ejection fraction [ Time Frame: 60 min ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiac index [ Time Frame: 60 min ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: May 2005
Study Completion Date: November 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600041

Locations
Germany
Dept. of Cardiology and Pneumology; Herzzentrum Goettingen
Goettingen, Germany, 37099
Sponsors and Collaborators
Herzzentrum Goettingen
Thoracic, Cardiac and Vascular Surgery, University Medicine of Goettingen
Gastroenterology and Endocrinology, University Medicine of Goettingen
Medical Statistics, University Medicine of Goettingen
Investigators
Principal Investigator: Gerd Hasenfuss, Prof. Dr. Herzzentrum Goettingen
  More Information

Additional Information:
Herzzentrum Goettingen - Heart Center of Goettingen  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Gerd Hasenfuss/Prof. Dr., Head of dept. of Cardiology and Pneumology, Herzzentrum Goettingen, Dept. of Cardiology and Pneumology
ClinicalTrials.gov Identifier: NCT00600041     History of Changes
Other Study ID Numbers: HIPPO1-2004-11-01, 2004-004355-18 (EudraCT)
Study First Received: January 11, 2008
Last Updated: March 22, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013