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Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction

Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myocardial Infarction

Intervention: epoetin alfa (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University Medical Center Groningen

Official(s) and/or principal investigator(s):
A A Voors, MD,PhD, Principal Investigator, Affiliation: University Medical Center Groningen
F Zijlstra, MD,PhD,FACC, Principal Investigator, Affiliation: University Medical Center Groningen
DJ van Veldhuisen, MD,PhD,FACC, Principal Investigator, Affiliation: University Medical Center Groningen

Summary

The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.

Clinical Details

Official title: A Prospective, Randomised, Clinical Study to Examine the Effects of a Single Bolus Erythropoietin on Left Ventricular Function in Patients With an Acute Myocardial Infarction

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography

Secondary outcome: Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO

Detailed description: Erythropoetin (EPO) is commonly known as an effective treatment for anemia. However, several important extra-hematopoeitic effects of EPO are suggested which might be beneficial in the setting of an acute myocardial infarction, such as a reduction of apoptosis and stimulation of neovascularisation. Recent animal studies provided very consistent evidence for a reduced infarct size and improved left ventricular function caused by EPO administration. However, clinical studies with EPO in non-anemic patients are scarce. We performed a safety study in our department on the effects of a single bolus of EPO in patients with an acute myocardial infarction. Serum EPO levels increased a 200-fold and EPO administration was not associated with hypertension, nor with an increase in thrombocytes or thrombotic events. In conclusion, experimental data clearly showed that a single bolus of EPO after the onset of an acute myocardial infarction reduced myocardial infarct size, and improved left ventricular function. In our safety study, EPO administration in patients with an acute myocardial infarction was safe and well tolerated. This will be a PROBE (Prospective, Randomised, Open label study with Blinded Endpoint) designed study, in wich one group will receive one bolus of EPO 60. 000 IU) intravenously within 3 hours after the primary PCI procedure and the other group will receive standard therapy. After 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:

- chest pain suggestive for acute myocardial infarction

- symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing

ischemia

- ECG with ST-T segment elevation > 1 mV in 2 or more leads

- TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;

Exclusion Criteria:

- Hemoglobin levels > 10. 6 mmol/L;

- Anticipated additional revascularisation within 4 months;

- Cardiogenic shock;

- Presence of other serious medical conditions

- Pregnancy/breast feeding

- Malignant hypertension

- End stage renal failure (creatinin > 220 micromol/l)

- Previous treatment with rh-EPO

- Blood transfusion <12 weeks prior to randomisation

- Polycythemia vera

- Previous acute myocardial infarction

- Concomitant inflammatory or malignant disease

- Recent trauma or major surgery

- Unwilling to sign informed consent

- Atrial fibrillation

Locations and Contacts

University Medical Center Groningen, Groningen 9700RB, Netherlands
Additional Information

Related publications:

Belonje AM, Voors AA, van Gilst WH, Anker SD, Slart RH, Tio RA, Zijlstra F, van Veldhuisen DJ; HEBE III investigators. Effects of erythropoietin after an acute myocardial infarction: rationale and study design of a prospective, randomized, clinical trial (HEBE III). Am Heart J. 2008 May;155(5):817-22. doi: 10.1016/j.ahj.2007.12.036.

Starting date: January 2007
Last updated: December 14, 2009

Page last updated: August 23, 2015

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