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

Phase 2

Completed

• Conditions: Shock, Cardiogenic; Heart Failure; Acute Myocardial Infarction
• Interventions: Drug: Pyruvate

• Registration Number: NCT00604331
• Lead Sponsor: Herzzentrum Goettingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-30
• Study Start: 2008-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Pyruvate	Pyruvate

Primary Outcome Measures

Name	Time	Method
Cardiac Output	60 minutes

Secondary Outcome Measures

Name	Time	Method
Cardiac Index	60 minutes
Arterial Pressure	60 minutes
Pulmonary capillary wedge pressure	60 minutes
Pulmonary artery pressure	60 minutes
systemic vascular resistance	60 minutes
pulmonary vascular resistance	60 minutes
heart rate	60 minutes
stroke volume	60 minutes
catecholamine need	60 minutes
safety	60 minutes

Trial Locations

Locations (1)

Herzzentrum Goettingen, Cardiology and Pneumology; 🇩🇪 Goettingen, Germany