Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction (HEBEIII)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
epoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring erythropoietin, myocardial infarction, PCI, left ventricular function
Eligibility 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
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Epoetin alfa
Arm Description
i.v bolus 60.000 IU epoetin alfa
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography
Secondary Outcome Measures
Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO
Full Information
NCT ID
NCT00449488
First Posted
March 18, 2007
Last Updated
December 14, 2009
Sponsor
University Medical Center Groningen
Collaborators
The Interuniversity Cardiology Institute of the Netherlands, Janssen-Cilag Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00449488
Brief Title
Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Medical Center Groningen
Collaborators
The Interuniversity Cardiology Institute of the Netherlands, Janssen-Cilag Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
erythropoietin, myocardial infarction, PCI, left ventricular function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
529 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Epoetin alfa
Arm Type
Active Comparator
Arm Description
i.v bolus 60.000 IU epoetin alfa
Intervention Type
Drug
Intervention Name(s)
epoetin alfa
Other Intervention Name(s)
Eprex
Intervention Description
epoetin alfa 60.000 IU one i.v. bolus
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO
Time Frame
Cardiovascular Events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A A Voors, MD,PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
F Zijlstra, MD,PhD,FACC
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DJ van Veldhuisen, MD,PhD,FACC
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700RB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
18440327
Citation
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.
Results Reference
background
PubMed Identifier
20802250
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction
We'll reach out to this number within 24 hrs