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

This study has been completed.
Sponsor:
Information provided by:
Herzzentrum Goettingen
ClinicalTrials.gov Identifier:
NCT00604331
First received: January 17, 2008
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Shock, Cardiogenic
Heart Failure
Acute Myocardial Infarction
Drug: Pyruvate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation

Resource links provided by NLM:


Further study details as provided by Herzzentrum Goettingen:

Primary Outcome Measures:
  • Cardiac Output [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiac Index [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • Arterial Pressure [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • Pulmonary capillary wedge pressure [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • Pulmonary artery pressure [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • systemic vascular resistance [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • pulmonary vascular resistance [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • heart rate [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • stroke volume [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • catecholamine need [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • safety [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Pyruvate
Drug: Pyruvate
sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604331

Locations
Germany
Herzzentrum Goettingen, Cardiology and Pneumology
Goettingen, Germany, 37075
Sponsors and Collaborators
Herzzentrum Goettingen
Investigators
Principal Investigator: Gerd Hasenfuss, Prof. Dr. Herzzentrum Goettingen, Cardiology and Pneumology
  More Information

Additional Information:
Publications:
Responsible Party: Gerd Hasenfuss/Professor Dr. med., Cardiology and Pneumology
ClinicalTrials.gov Identifier: NCT00604331     History of Changes
Other Study ID Numbers: PYR-2008-01, 12/10/00
Study First Received: January 17, 2008
Last Updated: December 7, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Herzzentrum Goettingen:
Pyruvic Acid
Shock, Cardiogenic
Catecholamines
Intra-Aortic Balloon Pumping
Cardiac Output
Cardiac Index
Cardiac Function

Additional relevant MeSH terms:
Shock
Shock, Cardiogenic
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014