NCT00604331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

11 months

First QC Date

January 17, 2008

Last Update Submit

December 7, 2010

Conditions

Shock, CardiogenicHeart FailureAcute Myocardial Infarction

Keywords

Pyruvic AcidShock, CardiogenicCatecholaminesIntra-Aortic Balloon PumpingCardiac OutputCardiac IndexCardiac Function

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output

    60 minutes

Secondary Outcomes (10)

  • Cardiac Index

    60 minutes

  • Arterial Pressure

    60 minutes

  • Pulmonary capillary wedge pressure

    60 minutes

  • Pulmonary artery pressure

    60 minutes

  • systemic vascular resistance

    60 minutes

  • +5 more secondary outcomes

Study Arms (1)

A

ACTIVE COMPARATOR

Pyruvate

Drug: Pyruvate

Interventions

PyruvateDRUG

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

A

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Malignoma
  • Clinically significant cardiac valve stenosis
  • Participation in another clinical trial with relevant or probable drug-interactions
  • Pregnancy or lactation
  • Addiction
  • Poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzentrum Goettingen, Cardiology and Pneumology

Göttingen, 37075, Germany

Location

Related Publications (2)

  • 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.

    PMID: 10218531BACKGROUND

  • 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.

    PMID: 21132310RESULT

MeSH Terms

Conditions

Shock, CardiogenicHeart Failure

Interventions

Pyruvic Acid

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

PyruvatesKeto AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

  • Gerd Hasenfuss, Prof. Dr.

    Herzzentrum Goettingen, Cardiology and Pneumology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 30, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 9, 2010

Record last verified: 2010-12

Locations

DE(1)