Condition category
Circulatory System
Date applied
26/05/2006
Date assigned
26/05/2006
Last edited
24/08/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. Hogenhuis

ORCID ID

Contact details

University Medical Center Groningen (UMCG)
Trial Coordiantion Center
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3618061
j.hogenhuis@thorax.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00449488

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HEBE III

Study hypothesis

A single bolus erythropoietin (EPO) administered just before a primary percutaneous coronary intervention (PCI) for a first acute myocardial infarction will increase left ventricular function after four months.

Ethics approval

Ethics approval details not yet received as of 26/05/06

Study design

Prospective, randomised, double-blind, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Myocard infarction

Intervention

One bolus of EPO (Eprex, about 60.000 IU) will be administered intravenously in 30 minutes, within 3 hours after the primary PCI procedure versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Erythropoietin

Primary outcome measures

The main study endpoint will be left ventricular ejection faction, measured with cardiac magnetic resonance imaging at four months after onset of the acute myocardial infarction

Secondary outcome measures

Secondary study endpoints are:
1. Myocardial infarct size, summarised as the percentage of left ventricular mass, measured with cardiac magnetic resonance imaging at four months after onset of the acute myocardial infarction
2. Cardiovascular events (cardiovascular death, re-myocardial infarction, re-PCI or coronary artery bypass graft (CABG), stroke, heart failure) from the onset of the acute myocardial infarction to four months afterwards
3. Enzymatic infarct size with computerised measurements of creatine kinase (CK) and creatine kinase myocardial band (CK-MB)
4. Safety endpoint: incidence of death, stroke, onset or worsening of congestive heart failure (CHF), deep vein thrombosis, malignant hypertension (risk ratio [RR] >250/125), re-myocardial infarction, pulmonary embolism, seizure

Overall trial start date

01/09/2006

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Successful primary PCI (thrombin inhibition in myocardial infarction [TIMI] 2/3) for a first acute myocardial infarction, diagnosed by:
1. Chest pain suggestive of acute myocardial infarction
2. Symptom onset <12 hours after hospital admission, or <24 hours in case ongoing ischemia
3. Electrocardiogram (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 spinothalamic tract

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Hemoglobin levels >10.6 mmol/l
2. Anticipated additional revascularisation within four months
3. Cardiogenic shock
4. Presence of other serious medical conditions
5. Pregnant/breast feeding
6. Malignant hypertension
7. End stage renal failure (creatinine >220 micromol/l)
8. Previous treatment with recombinant human erythropoietin (rh-EPO)
9. Blood transfusion <12 weeks prior to randomisation
10. Allergy against rh-EPO
11. Polycythemia vera
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 magnetic resonance imaging (MRI) (pacemaker and other metal subjects)

Recruitment start date

01/09/2006

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

Trial Coordination Center
P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Medical Center Groningen (UMCG) and Interuniversity Institute of Cardiology (ICIN), The Netherlands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes