Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction

University Medicine Greifswald

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Coronary Heart Disease

Heart Failure

Treatments

Device: Immunoadsorption / Immunoglobulin substitution

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00738517

MPG 01/08

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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