Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction (HEBEIII)

December 14, 2009 updated by: University Medical Center Groningen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

529

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Eprex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO
Time Frame: Cardiovascular Events
Cardiovascular Events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Janssen-Cilag Ltd.
The Interuniversity Cardiology Institute of the Netherlands

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

March 18, 2007

First Submitted That Met QC Criteria

March 18, 2007

First Posted (Estimate)

March 20, 2007

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 14, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B213
  • ISRCTN46528154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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