Chronic, Low Dose Erythropoetin Beta in Ischemic Cardiomyopathy

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is testing the hypothesis, that the application of low dose erythropoetin beta (35 I.E./kg BW/week) for 6 months following successful coronary revascularization by PCI improves left ventricular remodeling as assessed by cardiac MRI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• successful coronary intervention < 14 days

• regional contraction deficit of the left ventricle as detected either by echocardiography or cardiacMRI

• globally reduced ejection fraction (cardiac MRI or echocardiography: < 60%)

• willing and able to cooperate

• voluntary participation

Exclusion Criteria:

• contraindication for cardiac MRI (i.e. pacemaker, ICD current or within the next 6 months, other metal implants)

• cardiogenic shock at time of inclusion

• uncontrolled hypertension (systolic blood pressure > 180mmHg)

• hemoglobin > 16mg/dl

• thrombocytosis

• malignant tumor

• missing informed consent

• renal failure (creatinine > 300 mg/dl)

• liver failure

• other prognosis limiting, severe diseases (i.e. dementia)

• indication for open label erythropoietin treatment

• allergy towards solvents of the EPO preparation

• woman of childbearing potential

• other clinical study within the preceding 30days

• known alcohol or drug abuse

• neurologic or psychiatry disorders

• previous organ transplantation