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Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction (HEBEIII)
This study has been completed.

First Received on March 18, 2007.   Last Updated on December 14, 2009   History of Changes
Sponsor: University Medical Centre Groningen
Collaborators: The Interuniversity Cardiology Institute of the Netherlands
Janssen-Cilag Ltd.
Information provided by: University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00449488
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: epoetin alfa
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Clinical Study to Examine the Effects of a Single Bolus Erythropoietin on Left Ventricular Function in Patients With an Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO [ Time Frame: Cardiovascular Events ] [ Designated as safety issue: No ]

Enrollment: 529
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Active Comparator: Epoetin alfa
i.v bolus 60.000 IU epoetin alfa
Drug: epoetin alfa
epoetin alfa 60.000 IU one i.v. bolus
Other Name: Eprex

Detailed Description:

Erythropoetin (EPO) is commonly known as an effective treatment for anemia. However, several important extra-hematopoeitic effects of EPO are suggested which might be beneficial in the setting of an acute myocardial infarction, such as a reduction of apoptosis and stimulation of neovascularisation. Recent animal studies provided very consistent evidence for a reduced infarct size and improved left ventricular function caused by EPO administration. However, clinical studies with EPO in non-anemic patients are scarce.

We performed a safety study in our department on the effects of a single bolus of EPO in patients with an acute myocardial infarction. Serum EPO levels increased a 200-fold and EPO administration was not associated with hypertension, nor with an increase in thrombocytes or thrombotic events.

In conclusion, experimental data clearly showed that a single bolus of EPO after the onset of an acute myocardial infarction reduced myocardial infarct size, and improved left ventricular function. In our safety study, EPO administration in patients with an acute myocardial infarction was safe and well tolerated.

This will be a PROBE (Prospective, Randomised, Open label study with Blinded Endpoint) designed study, in wich one group will receive one bolus of EPO 60.000 IU) intravenously within 3 hours after the primary PCI procedure and the other group will receive standard therapy. After 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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;

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449488

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
The Interuniversity Cardiology Institute of the Netherlands
Janssen-Cilag Ltd.
Investigators
Principal Investigator: A A Voors, MD,PhD University Medical Centre Groningen
Principal Investigator: F Zijlstra, MD,PhD,FACC University Medical Centre Groningen
Principal Investigator: DJ van Veldhuisen, MD,PhD,FACC University Medical Centre Groningen
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A.A. Voors, University Medical Center Groningen, department of Cardiology
ClinicalTrials.gov Identifier: NCT00449488     History of Changes
Other Study ID Numbers: B213, ISRCTN46528154
Study First Received: March 18, 2007
Last Updated: December 14, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
erythropoietin
myocardial infarction
PCI
left ventricular function

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012