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

Myocardial Infarction Clinical Trial

— HEBEIII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449488
• Other study ID #: B213
• Secondary ID: ISRCTN46528154
• Status: Completed
• Phase: Phase 2
• First received: March 18, 2007
• Last updated: December 14, 2009
• Start date: January 2007
• Est. completion date: October 2009

Study information

• Verified date: December 2009
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• epoetin alfa
epoetin alfa 60.000 IU one i.v. bolus

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	Janssen-Cilag Ltd., The Interuniversity Cardiology Institute of the Netherlands

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography		6 weeks	No
Secondary	Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO		Cardiovascular Events	No