Shock, CardiogenicPhase 2NCT00604331
Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation
A Phase 2 study testing Pyruvate in people with Shock, Cardiogenic and Heart Failure, run by Herzzentrum Goettingen at 1 site in Germany.
Trial summary
Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive inotropic effects in vitro and in vivo without altering myocardial oxygen consumption. Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shock, Cardiogenic, Heart Failure, Acute Myocardial Infarction
- What is being tested?
- Pyruvate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Jul 2009
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients male/female
- Age: 18 - 85 years
- Weight: 45 - 110 kg
- Height 150 - 195 cm
- Clinically signs of heart failure (NYHA III-IV) refractary to therapy or cardiogenic shock in acute myocardial infarction
- written informed consent or witnessed verbal consent or presumed will (compassionate use)
Who cannot join
- Malignoma
- Clinically significant cardiac valve stenosis
- Participation in another clinical trial with relevant or probable drug-interactions
- Pregnancy or lactation
- Addiction
- Poor compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Herzzentrum Goettingen, Cardiology and Pneumology
Göttingen, 37075
About this study
Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive inotropic effects in vitro and in vivo without altering myocardial oxygen consumption. Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated. Thus, it might be possible to save catecholamines in patients with severe heart failure or cardiogenic shock. This study was designed to test the hemodynamic effects of pyruvate administered into a coronary artery in addition to intra-aortic balloon pump counterpulsation in patients with severe heart failure or in patients with acute myocardial infarction and cardiogenic shock after having performed percutaneous coronary intervention. A pronounced improvement in hemodynamics is expected to occur.
- Being tested
- Pyruvate
- Keywords
- Pyruvic Acid, Shock, Cardiogenic, Catecholamines, Intra-Aortic Balloon Pumping, Cardiac Output, Cardiac Index, Cardiac Function
- Medical subject headings
- Shock, Cardiogenic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyruvateDrug
sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Pyruvate Receives: Drug: Pyruvate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Measured: 60 minutes
Secondary outcomes (10)
Cardiac Index
Measured: 60 minutes
Arterial Pressure
Measured: 60 minutes
Pulmonary capillary wedge pressure
Measured: 60 minutes
Pulmonary artery pressure
Measured: 60 minutes
systemic vascular resistance
Measured: 60 minutes
pulmonary vascular resistance
Measured: 60 minutes
heart rate
Measured: 60 minutes
stroke volume
Measured: 60 minutes
catecholamine need
Measured: 60 minutes
safety
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shock, CardiogenicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herzzentrum Goettingen
- Sponsor type
- University, hospital or other
- Investigators
- Gerd Hasenfuss, Prof. Dr., Principal investigator, Herzzentrum Goettingen, Cardiology and Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604331
- Sponsor's protocol ID
- PYR-2008-01
- Other IDs
- 12/10/00
- Status last verified
- Dec 2010
- First submitted
- 17 Jan 2008
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermann HP, Pieske B, Schwarzmuller E, Keul J, Just H, Hasenfuss G. Haemodynamic effects of intracoronary pyruvate in patients with congestive heart failure: an open study. Lancet. 1999 Apr 17;353(9161):1321-3. doi: 10.1016/s0140-6736(98)06423-x.
PubMed 10218531Schillinger W, Hunlich M, Sossalla S, Hermann HP, Hasenfuss G. Intracoronary pyruvate in cardiogenic shock as an adjunctive therapy to catecholamines and intra-aortic balloon pump shows beneficial effects on hemodynamics. Clin Res Cardiol. 2011 May;100(5):433-8. doi: 10.1007/s00392-010-0261-4. Epub 2010 Dec 4.
PubMed 21132310
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation
- ClinicalTrials.gov ID
- NCT00604331
- Acronym / sponsor ID
- PYR-2008-01
- Keywords
- Pyruvic Acid, Shock, Cardiogenic, Catecholamines, Intra-Aortic Balloon Pumping, Cardiac Output, Cardiac Index, Cardiac Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Herzzentrum GoettingenUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 30 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.
Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive inotropic effects in vitro and in vivo without altering myocardial oxygen consumption. Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated. Thus, it might be possible to save catecholamines in patients with severe heart failure or cardiogenic shock. This study was designed to test the hemodynamic effects of pyruvate administered into a coronary artery in addition to intra-aortic balloon pump counterpulsation in patients with severe heart failure or in patients with acute myocardial infarction and cardiogenic shock after having performed percutaneous coronary intervention. A pronounced improvement in hemodynamics is expected to occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: PyruvatePyruvate |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized patients male/female
- Age: 18 - 85 years
- Weight: 45 - 110 kg
- Height 150 - 195 cm
- Clinically signs of heart failure (NYHA III-IV) refractary to therapy or cardiogenic shock in acute myocardial infarction
Key exclusion criteria (6 listed)
- Malignoma
- Clinically significant cardiac valve stenosis
- Participation in another clinical trial with relevant or probable drug-interactions
- Pregnancy or lactation
- Addiction
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 |
|---|---|---|
| Pyruvatesodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes. | Drug | A |
Primary outcome
Cardiac Output
Time frame: 60 minutes
10 secondary outcomes
Cardiac Index
Time frame: 60 minutes
Arterial Pressure
Time frame: 60 minutes
Pulmonary capillary wedge pressure
Time frame: 60 minutes
Pulmonary artery pressure
Time frame: 60 minutes
systemic vascular resistance
Time frame: 60 minutes
pulmonary vascular resistance
Time frame: 60 minutes
heart rate
Time frame: 60 minutes
stroke volume
Time frame: 60 minutes
catecholamine need
Time frame: 60 minutes
safety
Time frame: 60 minutes
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 9 Dec 2010.
- Background: PubMed 10218531Hermann HP, Pieske B, Schwarzmuller E, Keul J, Just H, Hasenfuss G. Haemodynamic effects of intracoronary pyruvate in patients with congestive heart failure: an open study. Lancet. 1999 Apr 17;353(9161):1321-3. doi: 10.1016/s0140-6736(98)06423-x.
- Results publication: PubMed 21132310Schillinger W, Hunlich M, Sossalla S, Hermann HP, Hasenfuss G. Intracoronary pyruvate in cardiogenic shock as an adjunctive therapy to catecholamines and intra-aortic balloon pump shows beneficial effects on hemodynamics. Clin Res Cardiol. 2011 May;100(5):433-8. doi: 10.1007/s00392-010-0261-4. Epub 2010 Dec 4.
- 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, Cardiology and Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyruvate in people with Shock, Cardiogenic and Heart Failure, 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 6 inclusion and 6 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 9 Dec 2010. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cardiac Output (time frame: 60 minutes). 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 NCT00604331, which also lists 2 linked publications.
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 9 Dec 2010.