HEBE III: A prospective, randomised, clinical study to examine the effects of a single bolus erythropoietin on left ventricular function in patients with an acute myocardial infarctio

Phase 3

Recruiting

• Conditions: heart attack; myocardial infarction; 10011082

• Registration Number: NL-OMON30616
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 466

Inclusion Criteria

Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:
a. chest pain suggestive for acute myocardial infarction
b. symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia
c. ECG with ST-T segment elevation > 1 mV in 2 or more leads
d. TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;

Exclusion Criteria

a. Hemoglobin levels > 10.6 mmol/L;
b. Anticipated additional revascularisation within 6 weeks;
c. Cardiogenic shock;
d. Presence of other serious medical conditions
e. Pregnancy/breast feeding
f. Malignant hypertension
g. End stage renal failure (kreatinin > 220 micromol/l)
h. Previous treatment with rh-EPO
i. Blood transfusion <12 weeks prior to randomisation
j. Allergy against rh-EPO
k. Polycytemia verae
l. Previous acute myocardial infarction
m. Concomitant inflammatory or malignant disease
n. Recent trauma or major surgery
o. Unwilling to sign informed consent
p. Atrium fibrillation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of the study is left ventricular ejection fraction, measured<br /><br>with planar radionuclide ventriculography at 6 weeks after onset of the acute<br /><br>myocardial infarction</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>