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Trial NCT00738517

Resource URI: http://static.linkedct.org/resource/trials/NCT00738517
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/13830>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/5467>
linkedct:brief_title Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/2896>
linkedct:condition <http://static.linkedct.org/resource/condition/3389>
linkedct:condition <http://static.linkedct.org/resource/condition/5704>
linkedct:criteria Inclusion Criteria: - heart failure and known coronary heart disease / post myocardial infarction - completed treatment for coronary heart disease (no known hemodynamically effective stenosis in coronary vessels) - evidence of scarred myocardial tissue in low-dose stress echocardiography or myocardial scintigraphy or MRI - evidence of hypo-contractile myocardium in echocardiography or MRI outside of infarction area - at least 3 months without acute coronary syndrome or coronary intervention - left-ventricular ejection fraction by echocardiography < 45% - detection of at least one myocardial autoantibody (e.g. anti-ß1-receptor, anti-TnI, anti-KchIP2) in serum - dyspnea on exertion equivalent to NYHA II - NYHA IV - written informed consent of the patient Exclusion Criteria: - heart failure due to other cardiac disease (e.g. dilatative cardiomyopathy without evidence of CHD, primary valve defects > II°, toxic cardiomyopathy) - active infection - pregnancy - malign tumor disease - other secondary disease with life expectancy < 1 year - refusal by the patient
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2010
linkedct:enrollment 40 (xsd:int)
linkedct:firstreceived_date August 18, 2008
linkedct:has_dmc No
linkedct:id NCT00738517
linkedct:intervention <http://static.linkedct.org/resource/intervention/40241>
rdfs:label Trial NCT00738517
linkedct:lastchanged_date May 4, 2009
linkedct:lead_sponsor_agency Ernst Moritz Arndt University of Greifswald
linkedct:location <http://static.linkedct.org/resource/location/270887>
linkedct:nct_id NCT00738517
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction
linkedct:org_study_id MPG 01/08
linkedct:overall_contact_email staudt@uni-greifswald.de
linkedct:overall_contact_last_name Alexander Staudt, MD
linkedct:overall_contact_phone +49-3834-867322
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/11255>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/1385>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28398>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/34149>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/37279>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/4634>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/55402>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1083>
foaf:page <http://clinicaltrials.gov/show/NCT00738517>
linkedct:phase Phase 1/Phase 2
linkedct:primary_completion_date June 2010
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/47174>
linkedct:reference <http://static.linkedct.org/resource/reference/10348>
linkedct:reference <http://static.linkedct.org/resource/reference/19843>
linkedct:reference <http://static.linkedct.org/resource/reference/52141>
linkedct:reference <http://static.linkedct.org/resource/reference/55935>
linkedct:reference <http://static.linkedct.org/resource/reference/7126>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/15428>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/33728>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/68595>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/77581>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/78634>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/99991>
linkedct:source Ernst Moritz Arndt University of Greifswald
linkedct:start_date September 2008
linkedct:study_design Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date May 2009