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

Herzzentrum Goettingen

Status and phase

Completed

Phase 2

Conditions

Heart Failure

Acute Myocardial Infarction

Shock, Cardiogenic

Treatments

Drug: Pyruvate

Study type

Interventional

Funder types

Other

Identifiers

NCT00604331

PYR-2008-01

12/10/00

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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