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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herzzentrum Goettingen

Criteria

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:

• Malignoma

• Clinically significant cardiac valve stenosis

• Participation in another clinical trial with relevant or probable drug-interactions

• Pregnancy or lactation

• Addiction

• Poor compliance