Placebo-Controlled Crossover Study for the Investigation of the Effect of Pantoprazole on Cardiac Contractility (HIPPO)
|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)|
- Echocardiographic ejection fraction [ Time Frame: 60 min ] [ Designated as safety issue: Yes ]
- Cardiac index [ Time Frame: 60 min ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Study Completion Date:||November 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes
Placebo Comparator: B
NaCl 0.9% IV
Identical infusion manner like experimental arm
Other Name: NaCl 0.9%
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600041
|Dept. of Cardiology and Pneumology; Herzzentrum Goettingen|
|Goettingen, Germany, 37099|
|Principal Investigator:||Gerd Hasenfuss, Prof. Dr.||Herzzentrum Goettingen|