Clinical trial NCT00604331: Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation
Official title: Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Shock, Cardiogenic
Heart Failure
Acute Myocardial Infarction
Keywords: Pyruvic Acid
Shock, Cardiogenic
Catecholamines
Intra-Aortic Balloon Pumping
Cardiac Output
Cardiac Index
Cardiac Function
Lead sponsor: Herzzentrum Goettingen
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Cardiac Output
timeFrame: 60 minutes
Secondary outcomes:
measure: Cardiac Index
timeFrame: 60 minutes
measure: Arterial Pressure
timeFrame: 60 minutes
measure: Pulmonary capillary wedge pressure
timeFrame: 60 minutes
measure: Pulmonary artery pressure
timeFrame: 60 minutes
measure: systemic vascular resistance
timeFrame: 60 minutes
measure: pulmonary vascular resistance
timeFrame: 60 minutes
measure: heart rate
timeFrame: 60 minutes
measure: stroke volume
timeFrame: 60 minutes
measure: catecholamine need
timeFrame: 60 minutes
measure: safety
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: Herzzentrum Goettingen, Cardiology and Pneumology
Study officials:
affiliation: Herzzentrum Goettingen, Cardiology and Pneumology
name: Gerd Hasenfuss, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.