Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction

Conditions
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Heart Failure, Coronary Heart Disease

Intervention / Treatment
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* Device: Immunoadsorption / Immunoglobulin substitution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Immunoadsorption with subsequent immunoglobulin substitution | Device: Immunoadsorption / Immunoglobulin substitution<br>* Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)<br>* Other names: Immunosorba;|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left-ventricular ejection fraction as measured by echocardiography |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index |  | 6 months | 
| systemic vascular resistance |  | 6 months | 
| pulmonary vascular resistance |  | 6 months | 
| n-terminal pro-BNP concentration (serum) |  | 6 months | 
| peak oxygen uptake (spiroergometric) |  | 6 months | 
| dyspnoea symptoms / NYHA classification |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, coronary heart disease, autoantibodies, immunoadsorption, immunoglobulin substitution