HealthyPhase 1HIPPONCT00600041
Placebo-Controlled Crossover Study for the Investigation of the Effect of Pantoprazole on Cardiac Contractility
A Phase 1 study testing Pantoprazole in people with Healthy, run by Herzzentrum Goettingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pantoprazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2005to Nov 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy and lactation
- No or insufficient contraception
- Intolerance of pantoprazole
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Cardiology and Pneumology; Herzzentrum Goettingen
Göttingen, 37099
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Pantoprazole, Placebo
- Keywords
- Proton Pump Inhibitors, pantoprazole, Cardiac Output, Echocardiography, adverse effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Also called Pantozol i.v., Protonix I.V.
80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes
PlaceboDrug
Also called NaCl 0.9%
Identical infusion manner like experimental arm
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Pantoprazole IV Receives: Drug: Pantoprazole |
| B | Placebo comparator | NaCl 0.9% IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic ejection fraction
Measured: 60 min
Secondary outcomes (1)
Cardiac index
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startMay 2005
- Primary completionJan 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herzzentrum Goettingen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Göttingen, Gastroenterology and Endocrinology, University Medicine of Goettingen, Medical Statistics, University Medicine of Goettingen
- Investigators
- Gerd Hasenfuss, Prof. Dr., Principal investigator, Herzzentrum Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600041
- Sponsor's protocol ID
- HIPPO1-2004-11-01
- Other IDs
- 2004-004355-18 (EudraCT), 2004
- Acronym
- HIPPO
- Status last verified
- Feb 2008
- First submitted
- 11 Jan 2008
- Last updated
- 24 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Schillinger W, Hornes N, Teucher N, Sossalla S, Sehrt D, Jung K, Hunlich M, Unsold B, Geiling B, Ramadori G, Hilgers R, Schworer H, Hasenfuss G. Recent in vitro findings of negative inotropy of pantoprazole did not translate into clinically relevant effects on left ventricular function in healthy volunteers. Clin Res Cardiol. 2009 Jun;98(6):391-9. doi: 10.1007/s00392-009-0012-6. Epub 2009 Mar 20.
PubMed 19301059
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Issues of PantoPrazOle (HIPPO)
- ClinicalTrials.gov ID
- NCT00600041
- Acronym / sponsor ID
- HIPPO / HIPPO1-2004-11-01
- Conditions
- Healthy
- Keywords
- Proton Pump Inhibitors, pantoprazole, Cardiac Output, Echocardiography, adverse effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Herzzentrum GoettingenUniversity, hospital or other
- Collaborators
- University of Göttingen, Gastroenterology and Endocrinology, University Medicine of Goettingen, Medical Statistics, University Medicine of Goettingen
- Study start
- May 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: PantoprazolePantoprazole IV |
| B | Placebo comparator | Drug: PlaceboNaCl 0.9% IV |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- History of cardiac disease
- History of other relevant pre-existing illness
- Pathologic findings in clinical examinations
- Pathologic echocardiographic findings
- Pathologic ECG findings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PantoprazoleAlso: Pantozol i.v., Protonix I.V.80 mg IV over 2 minutes, followed by 8 mg/h IV for 60 minutes | Drug | A |
| PlaceboAlso: NaCl 0.9%Identical infusion manner like experimental arm | Drug | B |
Primary outcome
Echocardiographic ejection fraction
Time frame: 60 min
1 secondary outcome
Cardiac index
Time frame: 60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
- Results publication: PubMed 19301059Schillinger W, Hornes N, Teucher N, Sossalla S, Sehrt D, Jung K, Hunlich M, Unsold B, Geiling B, Ramadori G, Hilgers R, Schworer H, Hasenfuss G. Recent in vitro findings of negative inotropy of pantoprazole did not translate into clinically relevant effects on left ventricular function in healthy volunteers. Clin Res Cardiol. 2009 Jun;98(6):391-9. doi: 10.1007/s00392-009-0012-6. Epub 2009 Mar 20.
- Herzzentrum Goettingen - Heart Center of GoettingenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd Hasenfuss, Prof. Dr. principal investigator
Herzzentrum Goettingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pantoprazole in people with Healthy, run by Herzzentrum Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic ejection fraction (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2009.