NCT00449488

Brief Summary

The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
529

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2007

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

Study Start

First participant enrolled

January 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

2.8 years

First QC Date

March 18, 2007

Last Update Submit

December 14, 2009

Conditions

Myocardial Infarction

Keywords

erythropoietinmyocardial infarctionPCIleft ventricular function

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography

    6 weeks

Secondary Outcomes (1)

  • Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO

    Cardiovascular Events

Study Arms (2)

Control

NO INTERVENTION

Epoetin alfa

ACTIVE COMPARATOR

i.v bolus 60.000 IU epoetin alfa

Drug: epoetin alfa

Interventions

epoetin alfaDRUG

epoetin alfa 60.000 IU one i.v. bolus

Also known as: Eprex
Epoetin alfa

Eligibility Criteria

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

You may qualify if:

  • Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:
  • chest pain suggestive for acute myocardial infarction
  • symptom onset \< 12 hour before hospital admission, or \< 24 hour in case ongoing ischemia
  • ECG with ST-T segment elevation \> 1 mV in 2 or more leads
  • TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;

You may not qualify if:

  • Hemoglobin levels \> 10.6 mmol/L;
  • Anticipated additional revascularisation within 4 months;
  • Cardiogenic shock;
  • Presence of other serious medical conditions
  • Pregnancy/breast feeding
  • Malignant hypertension
  • End stage renal failure (creatinin \> 220 micromol/l)
  • Previous treatment with rh-EPO
  • Blood transfusion \<12 weeks prior to randomisation
  • Polycythemia vera
  • Previous acute myocardial infarction
  • Concomitant inflammatory or malignant disease
  • Recent trauma or major surgery
  • Unwilling to sign informed consent
  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700RB, Netherlands

Location

Related Publications (2)

  • Belonje AM, Voors AA, van Gilst WH, Anker SD, Slart RH, Tio RA, Zijlstra F, van Veldhuisen DJ; HEBE III investigators. Effects of erythropoietin after an acute myocardial infarction: rationale and study design of a prospective, randomized, clinical trial (HEBE III). Am Heart J. 2008 May;155(5):817-22. doi: 10.1016/j.ahj.2007.12.036.

    PMID: 18440327BACKGROUND

  • Voors AA, Belonje AM, Zijlstra F, Hillege HL, Anker SD, Slart RH, Tio RA, van 't Hof A, Jukema JW, Peels HO, Henriques JP, Ten Berg JM, Vos J, van Gilst WH, van Veldhuisen DJ; HEBE III Investigators. A single dose of erythropoietin in ST-elevation myocardial infarction. Eur Heart J. 2010 Nov;31(21):2593-600. doi: 10.1093/eurheartj/ehq304. Epub 2010 Aug 29.

    PMID: 20802250DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • A A Voors, MD,PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • F Zijlstra, MD,PhD,FACC

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • DJ van Veldhuisen, MD,PhD,FACC

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2007

First Posted

March 20, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

NL(1)