Overview

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