Chronic, Low Dose Erythropoetin Beta in Ischemic Cardiomyopathy
Condition: Ischemic Cardiomyopathy
MeSH terms: Cardiomyopathies; Ischemia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Several effects known to be exerted by erythropoetin (EPO) directly in the heart independent
      of hemoglobin levels could be of value immediately after revascularization procedures in
      ischemic cardiac remodeling: the generation of new capillaries is enhanced by the
      mobilization of endothelial progenitor cells from the bone marrow. EPO is neuron- and
      cardio-protective after ischemia/reperfusion. Administration of EPO enhances neuronal
      progenitors to differentiate into functional neurons; this observation may also be valid for
      the cardiac compartment. The concept of organ-specific effects of EPO independent of
      hemoglobin levels is supported by the analysis of EPO analogues lacking hematopoietic
      activity. In humans, currently this concept can only be tested by the use of EPO-doses that
      do not affect hemoglobin levels. The concept is valid as clinical trials have been performed
      showing that doses as low as 5000 I.U. EPO once weekly increase the levels of endothelial
      progenitor cells in blood. On the other hand, recent clinical trials have also shown neutral
      or even deleterious effects of high dose EPO treatment raising hemoglobin levels to above
      12mg/dl in pre-dialysis patients concerning cardiovascular endpoints. Therefore, the chronic,
      hemoglobin-neutral administration of low doses of EPO might be a successful approach
      concerning ischemic cardiomyopathy.

      Study outline:

      This investigator initiated, double-blind, placebo-controlled study is testing the
      hypothesis, that low doses of erythropoietin beta (35 I.U./kg body weight) started within 14
      days after a successful percutaneous coronary intervention enhance left ventricular
      remodeling as determined by comparison of two cardiac MRI´s over a course of 6 months.
      Secondary endpoints include changes in diastolic dysfunction as measured by echocardiography,
      VO2 measured by spiroergometry and serum brain natriuretic peptide levels.
    

Intervention name(s): erythropoetin beta; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 35 I.E. kg body weight subcutaneous once per week for 6 months; 35 I.E. kg body weight placebo to erythropoetin beta
Other intervention name(s): NeoRecormom 10.000 I.E. Patronen Zul.Nr. EU/1/97/031/021-022; Placebo to NeoRecormon 10.000 patron
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cardiomyopathy; ischemia; percutaneous coronary intervention; remodeling