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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Shock, Cardiogenic; Acute Myocardial Infarction
• Intervention / Treatment: Drug: Pyruvate

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Goettingen, Germany, 37075
    • Herzzentrum Goettingen, Cardiology and Pneumology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Pyruvate	Drug: Pyruvate; sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiac Output	60 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Herzzentrum Goettingen
• Investigators: Principal Investigator: Gerd Hasenfuss, Prof. Dr., Herzzentrum Goettingen, Cardiology and Pneumology

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: January 17, 2008
• First Submitted That Met QC Criteria: January 17, 2008
• First Posted (Estimate): January 30, 2008

Study Record Updates

• Last Update Posted (Estimate): December 9, 2010
• Last Update Submitted That Met QC Criteria: December 7, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Shock, Cardiogenic; Cardiac Output; Catecholamines; Cardiac Function; Cardiac Index; Pyruvic Acid; Intra-Aortic Balloon Pumping
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: PYR-2008-01; 12/10/00