Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction

Phase 1

Withdrawn

• Conditions: Heart Failure; Coronary Heart Disease
• Interventions: Device: Immunoadsorption / Immunoglobulin substitution

• Registration Number: NCT00738517
• Lead Sponsor: University Medicine Greifswald

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 after myocardial infarction and presence of cardiac autoantibodies.

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, 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.

Study Timeline

• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-20
• Study Start: 2008-09
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Immunoadsorption / Immunoglobulin substitution	Immunoadsorption with subsequent immunoglobulin substitution

Primary Outcome Measures

Name	Time	Method
left-ventricular ejection fraction as measured by echocardiography	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ernst-Moritz-Arndt-Universität; 🇩🇪 Greifswald, MV, Germany