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 number | NCT00449488 |
| Secondary identifying numbers | N/A |
- 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
Scientific
University Medical Center Groningen (UMCG)
Trial Coordiantion Center
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3618061 |
|---|---|
| j.hogenhuis@thorax.umcg.nl |
Study information
| Study design | Prospective, randomised, double-blind, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Erythropoietin |
| Primary outcome measure | 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 study start date | 01/09/2006 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
University/education
University/education
Trial Coordination Center
P.O. Box 30001
Groningen
9700 RB
Netherlands
| abc@123.com | |
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
University/education
University Medical Center Groningen (UMCG) and Interuniversity Institute of Cardiology (ICIN), The Netherlands
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/05/2008 | 07/02/2019 | Yes | No |
| Results article | results | 01/11/2010 | 07/02/2019 | Yes | No |
Editorial Notes
07/02/2019: Publication reference added.
