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

NCT ID: NCT00604331

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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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

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Conditions

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Shock, Cardiogenic Heart Failure Acute Myocardial Infarction

Keywords

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Pyruvic Acid Shock, Cardiogenic Catecholamines Intra-Aortic Balloon Pumping Cardiac Output Cardiac Index Cardiac Function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Pyruvate

Group Type ACTIVE_COMPARATOR

Pyruvate

Intervention Type DRUG

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

Interventions

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Pyruvate

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herzzentrum Goettingen

OTHER

Sponsor Role lead

Responsible Party

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Cardiology and Pneumology

Principal Investigators

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Gerd Hasenfuss, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Goettingen, Cardiology and Pneumology

Locations

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Herzzentrum Goettingen, Cardiology and Pneumology

Göttingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 10218531 (View on PubMed)

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.

Reference Type RESULT
PMID: 21132310 (View on PubMed)

Other Identifiers

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12/10/00

Identifier Type: -

Identifier Source: secondary_id

PYR-2008-01

Identifier Type: -

Identifier Source: org_study_id