Status:
WITHDRAWN
Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction
Lead Sponsor:
University Medicine Greifswald
Collaborating Sponsors:
Fresenius Medical Care North America
Conditions:
Heart Failure
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 af...
Detailed 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, n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00738517
Start Date
September 1 2008
End Date
December 1 2011
Last Update
May 11 2016
Active Locations (1)
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1
Ernst-Moritz-Arndt-Universität
Greifswald, Mecklenburg-Vorpommern, Germany, 17475