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| Descriptive Information Fields | |||||||||
| Brief Title † | Chronic, Low Dose Erythropoetin Beta in Ischemic Cardiomyopathy | ||||||||
| Official Title † | Pilot Study to Assess the Effect of Low Dose Epoetin Beta Administered for Six Month in Patients With Ischemic Heart Failure Subjected to Percutaneous Coronary Intervention (PCI) | ||||||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Change in global left ventricular ejection fraction between initial examination at study entry and the 6 months follow up examination employing cardiac MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | The application of 35 I.E./kg body weight erythropoetin beta s.c. once per week for 6 months is well tolerated and safe in patients after PCI. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves left ventricular regional wall motion as assessed by cardiac MRI. [ Time Frame: 6 months ] [ Designated as safety issue: No ] 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months reduces serum levels of brain natriuretic peptide as a measure of heart failure. [ Time Frame: 6 months ] [ Designated as safety issue: No ] 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves peak VO2 as measured by spiroergometry [ Time Frame: 6 months ] [ Designated as safety issue: No ] 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves measures or cardiac diastolic dysfunction as assessed by echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ] 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves cardiac tissue texture aqs assessed by contrast-enhanced cardiac MRI [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
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| Condition † | Ischemic Cardiomyopathy | ||||||||
| Intervention † | Drug: erythropoetin beta Drug: placebo |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 60 | ||||||||
| Start Date † | May 2006 | ||||||||
| Completion Date | February 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 45 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Germany | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00568542 | ||||||||
| Organization ID | 8514077463 | ||||||||
| Secondary IDs †† | EudraCT number 2004-002646-35, EK 6 EA 3/015/05, KP-3910-4030711 | ||||||||
| Study Sponsor † | Charite University, Berlin, Germany | ||||||||
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| Investigators † |
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| Information Provided By | Charite University, Berlin, Germany | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | December 5, 2007 | ||||||||
| Last Updated Date | May 7, 2008 | ||||||||
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