Ignite Creation Date:
2024-05-05 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00738517
Status:
WITHDRAWN
Last Update Posted:
2016-05-11
First Post:
2008-08-18
Brief Title:
Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction
Status:
WITHDRAWN
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left center
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None