Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

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.

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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.

Conditions

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Heart Failure Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Immunoadsorption with subsequent immunoglobulin substitution

Group Type ACTIVE_COMPARATOR

Immunoadsorption / Immunoglobulin substitution

Intervention Type DEVICE

Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DEVICE

Other Intervention Names

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Immunosorba

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No