Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction
NCT ID: NCT00449488
Last Updated: 2009-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
529 participants
INTERVENTIONAL
2007-01-31
2009-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
No interventions assigned to this group
Epoetin alfa
i.v bolus 60.000 IU epoetin alfa
epoetin alfa
epoetin alfa 60.000 IU one i.v. bolus
Interventions
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epoetin alfa
epoetin alfa 60.000 IU one i.v. bolus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The Interuniversity Cardiology Institute of the Netherlands
OTHER_GOV
Janssen-Cilag Ltd.
INDUSTRY
University Medical Center Groningen
OTHER
Responsible Party
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University Medical Center Groningen, department of Cardiology
Principal Investigators
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A A Voors, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
F Zijlstra, MD,PhD,FACC
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
DJ van Veldhuisen, MD,PhD,FACC
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Countries
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References
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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.
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.
Other Identifiers
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ISRCTN46528154
Identifier Type: -
Identifier Source: secondary_id
B213
Identifier Type: -
Identifier Source: org_study_id