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

ISRCTN	ISRCTN46528154
DOI	https://doi.org/10.1186/ISRCTN46528154
ClinicalTrials.gov (NCT)	NCT00449488
Protocol serial number	N/A
Sponsor	University Medical Center Groningen (UMCG) (The Netherlands)
Funder	University Medical Center Groningen (UMCG) and Interuniversity Institute of Cardiology (ICIN), The Netherlands

Submission date: 26/05/2006
Registration date: 26/05/2006
Last edited: 07/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. Hogenhuis
Scientific

University Medical Center Groningen (UMCG)
Trial Coordiantion Center
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3618061
Email	j.hogenhuis@thorax.umcg.nl

Study information

Primary study design	Interventional
Study design	Prospective, randomised, double-blind, placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title	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
Study acronym	HEBE III
Study objectives	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(s)	Ethics approval details not yet received as of 26/05/06
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Erythropoietin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key 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
Key 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)
Date of first enrolment	01/09/2006
Date of final enrolment	01/09/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen (UMCG)

Groningen
9700 RB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2010	07/02/2019	Yes	No
Protocol article	protocol	01/05/2008	07/02/2019	Yes	No

Editorial Notes

07/02/2019: Publication reference added.