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Sponsors and Collaborators: |
Ernst Moritz Arndt University of Greifswald Fresenius Medical Care North America |
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Information provided by: | Ernst Moritz Arndt University of Greifswald |
ClinicalTrials.gov Identifier: | NCT00738517 |
The purpose of this study is to investigate, if immunoadsorption of autoantibodies with subsequent substitution of immunoglobulins is able to improve cardiac function of patients with heart failure after myocardial infarction and presence of cardiac autoantibodies.
Condition | Intervention | Phase |
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Heart Failure Coronary Heart Disease |
Device: Immunoadsorption / Immunoglobulin substitution |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction |
Estimated Enrollment: | 40 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Immunoadsorption with subsequent immunoglobulin substitution
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Device: Immunoadsorption / Immunoglobulin substitution
Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)
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2: No Intervention |
Heart failure due to coronary heart disease (CHD) remains one of the most frequent causes of death. Left-ventricular ejection fraction < 30% is associated with a 5-year mortality > 70%. Therefore, new strategies and therapies towards treatment of heart failure are needed.
Heart failure due to left ventricular dysfunction can develop in CHD beyond the area of myocardial infarction. Some of these patients develop myocardial autoantibodies, which have been shown to exert a negative inotropic effect. Their elimination by immunoadsorption has been shown to improve left ventricular function in dilatative cardiomyopathy. Immunoglobulins are substituted to minimize infection risk at a level, which has been shown not to effect cardiac function. This intervention might also ameliorate cardiac function in patients with heart failure due to other origins. This study therefore aims to evaluate the effect of immunoadsorption with subsequent immunoglobulin substitution.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexander Staudt, MD | +49-3834-867322 | staudt@uni-greifswald.de |
Contact: Lars R Herda, MD | +49-3834-866656 | herda@uni-greifswald.de |
Germany, MV | |
Ernst-Moritz-Arndt-Universität | |
Greifswald, MV, Germany, 17475 |
Study Director: | Alexander Staudt, MD | Ernst-Moritz-Arndt-Universität Greifswald |
Study Chair: | Stephan B Felix, MD | Ernst-Moritz-Arndt-Universität Greifswald |
Principal Investigator: | Lars R Herda, MD | Ernst-Moritz-Arndt-Universität Greifswald |
Principal Investigator: | Astrid Hummel, MD | Ernst-Moritz-Arndt-Universität Greifswald |
Principal Investigator: | Marcus Doerr, MD | Ernst-Moritz-Arndt-Universität Greifswald |
Principal Investigator: | Daniel Beug, MD | Ernst-Moritz-Arndt-Universität Greifswald |
Principal Investigator: | Joerg Ruppert, MD | Ernst-Moritz-Arndt-Universität Greifswald |
Responsible Party: | Ernst-Moritz-Arndt-Universität ( PD Dr. med. A. Staudt ) |
Study ID Numbers: | MPG 01/08 |
Study First Received: | August 18, 2008 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00738517 |
Health Authority: | Germany: Ethics Commission |
heart failure coronary heart disease autoantibodies immunoadsorption immunoglobulin substitution |
Arterial Occlusive Diseases Heart Failure Heart Diseases Myocardial Ischemia Vascular Diseases Ischemia Arteriosclerosis Coronary Disease |
Necrosis Antibodies Autoantibodies Immunoglobulin G Infarction Myocardial Infarction Coronary Artery Disease Immunoglobulins |
Pathologic Processes Immunologic Factors Physiological Effects of Drugs Cardiovascular Diseases Pharmacologic Actions |