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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604331
• Other study ID #: PYR-2008-01
• Secondary ID: 12/10/00
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2008
• Last updated: December 7, 2010
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2010
• Source: Herzzentrum Goettingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Heart Failure
• Myocardial Infarction
• Shock
• Shock, Cardiogenic

Intervention

Drug:
• Pyruvate
sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.

Locations

Country	Name	City	State
Germany	Herzzentrum Goettingen, Cardiology and Pneumology	Goettingen

Sponsors (1)

Lead Sponsor	Collaborator
Herzzentrum Goettingen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Hermann HP, Pieske B, Schwarzmüller 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. — View Citation

Schillinger W, Hünlich 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output		60 minutes	Yes
Secondary	Cardiac Index		60 minutes	Yes
Secondary	Arterial Pressure		60 minutes	Yes
Secondary	Pulmonary capillary wedge pressure		60 minutes	Yes
Secondary	Pulmonary artery pressure		60 minutes	Yes
Secondary	systemic vascular resistance		60 minutes	Yes
Secondary	pulmonary vascular resistance		60 minutes	Yes
Secondary	heart rate		60 minutes	Yes
Secondary	stroke volume		60 minutes	Yes
Secondary	catecholamine need		60 minutes	Yes
Secondary	safety		60 minutes	Yes

External Links

•   Heart Center of Goettingen