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Sponsored by: |
Charite University, Berlin, Germany |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00568542 |
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.
Condition | Intervention | Phase |
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Ischemic Cardiomyopathy |
Drug: erythropoetin beta Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months.
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Drug: erythropoetin beta
35 I.E. kg body weight subcutaneous once per week for 6 months
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2: Placebo Comparator
Placebo to erythropoetin beta.
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Drug: placebo
35 I.E. kg body weight placebo to erythropoetin beta
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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.
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Martin W Bergmann, MD | 49-309-401 ext 12916 | martin.bergmann@charite.de |
Contact: Heidrun Mehling, MD | 49-309-417 ext 2221 | heidrun.mehling@charite.de |
Germany | |
Charité Campus Buch | Recruiting |
Berlin, Germany, 13125 | |
Contact: Sibylle Schmidt, study nurse 49-9401 ext 12910 sibylle.schmidt@charite.de | |
Contact: Angelika Weber, secretary 49-309-401 ext 52950 angelika-weber@helios-kliniken.de | |
Sub-Investigator: Heidrun Mehling, MD | |
Sub-Investigator: Jens Jordan, MD | |
Charité Campus Virchow | Active, not recruiting |
Berlin, Germany, 13353 |
Principal Investigator: | Martin W Bergmann, MD | Charité Camous Buch, University Medicine Berlin, Germany |
Responsible Party: | Charité Campus Buch, University Medicine Berlin, Germany ( Priv.-Doz. Dr. Martin W. Bergmann ) |
Study ID Numbers: | 8514077463, EudraCT number 2004-002646-35, EK 6 EA 3/015/05, KP-3910-4030711 |
Study First Received: | December 5, 2007 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00568542 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
cardiomyopathy ischemia percutaneous coronary intervention remodeling |
Epoetin Alfa Heart Failure Heart Diseases |
Hematinics Ischemia Cardiomyopathies |
Epoetin Alfa Heart Diseases Pathologic Processes Hematinics Therapeutic Uses |
Hematologic Agents Cardiovascular Diseases Ischemia Cardiomyopathies Pharmacologic Actions |