NL-OMON26840Not yet recruitingNot Applicable
HEBE III: A prospective, randomised, double blind, placebo controlled clinical study to examine the effects of a single bolus erythropoietin on left ventricular function in patients with an acute myocardial infarction.
Inter Cardiological Institute NetherlandsVan Buchem Stichting (UMCG)0 sites400 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 400
Study Overview
Brief Summary
/A
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:
- •1. Chest pain suggestive for acute myocardial infarction;
- •2. Symptom onset < 12 hour after hospital admission, or < 24 hour in case ongoing ischemia;
- •3. ECG with ST-T segment elevation > 1 mV in 2 or more leads;
- •4. TIMI flow 0/1 before primary PCI on diagnostic coronary angiography.
Exclusion Criteria
- •1. Hemoglobin levels > 10.6 mmol/L;
- •2. Anticipated additional revascularisation within 4 months;
- •3. Cardiogenic shock;
- •4. Presence of other serious medical conditions;
- •5. Pregnancy/breast feeding;
- •6. Malignant hypertension;
- •7. End stage renal failure (kreatinin > 220 micromol/l);
- •8. Previous treatment with rh-EPO;
- •9. Blood transfusion <12 weeks prior to randomisation;
- •10. Allergy against rh-EPO;
- •11. Polycytemia verae;
- •12. Previous acute myocardial infarction;
- •13. Concomitant inflammatory or malignant disease;
- •14. Recent trauma or major surgery;
- •15. Unwilling to sign informed consent;
- •16. Contra-indications for MRI (pacemaker and other metal subjects).
Investigators
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