CompletedNCT00604331Updated Dec 9, 2010

Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation

A Phase 2 interventional study of Pyruvate in Shock, Cardiogenic, Heart Failure and Acute Myocardial Infarction, sponsored by Herzzentrum Goettingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-12-09.

Sponsored by Herzzentrum Goettingen · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 18 Years to 85 Years
Sex: All

Study 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. 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.

Conditions studied

Shock, Cardiogenic
Heart Failure
Acute Myocardial Infarction

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Keywords

Pyruvic Acid
Shock, Cardiogenic
Catecholamines
Intra-Aortic Balloon Pumping
Cardiac Output
Cardiac Index
Cardiac Function

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 8 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Herzzentrum Goettingen is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

Malignoma
Clinically significant cardiac valve stenosis
Participation in another clinical trial with relevant or probable drug-interactions
Pregnancy or lactation
Addiction
Poor compliance

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Active comparator
A
Pyruvate
Drug: Pyruvate

Interventions

DrugPyruvate
sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.

What researchers measure

Primary outcomes

Cardiac Output
Time frame: 60 minutes

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

Study locations

1 site

Herzzentrum Goettingen, Cardiology and Pneumology
Goettingen, 37075, Germany

References and documents

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 10218531 ↗
Schillinger 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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00604331
Lead sponsor: Herzzentrum Goettingen
First posted: Jan 30, 2008
Start date: Aug 2008
Primary completion: Jul 2009
Completion: Jul 2009
Last update: Dec 9, 2010

Study contacts

Gerd Hasenfuss, Prof. Dr.

principal investigator · Herzzentrum Goettingen, Cardiology and Pneumology

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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