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| Sponsor: | Charite University, Berlin, Germany |
|---|---|
| Information provided by: | Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00568542 |
Purpose
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 |
|---|---|---|
|
Ischemic Cardiomyopathy |
Drug: erythropoetin beta Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
| Enrollment: | 28 |
| Study Start Date: | May 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months. The drug is self-administered.
|
Drug: erythropoetin beta
35 I.E. kg body weight subcutaneous once per week for 6 months
Other Name: NeoRecormom 10.000 I.E. Patronen Zul.Nr. EU/1/97/031/021-022
|
|
Placebo Comparator: 2
Placebo to erythropoetin beta.
|
Drug: placebo
35 I.E. kg body weight placebo to erythropoetin beta
Other Name: Placebo to NeoRecormon 10.000 patron
|
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.
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Charité Campus Buch | |
| Berlin, Germany, 13125 | |
| Charité Campus Virchow | |
| Berlin, Germany, 13353 | |
| Principal Investigator: | Martin W Bergmann, MD | Charité Camous Buch, University Medicine Berlin, Germany |
More Information
| Responsible Party: | Priv.-Doz. Dr. Martin W. Bergmann, Charité Campus Buch, University Medicine Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00568542 History of Changes |
| Other 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: | August 3, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
cardiomyopathy ischemia percutaneous coronary intervention remodeling |
|
Ischemia Cardiomyopathies Pathologic Processes Heart Diseases Cardiovascular Diseases |
Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |