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Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Medicine Greifswald.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00738517
First received: August 18, 2008
Last updated: June 17, 2010
Last verified: June 2010

August 18, 2008
June 17, 2010
September 2008
June 2011   (final data collection date for primary outcome measure)
left-ventricular ejection fraction as measured by echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00738517 on ClinicalTrials.gov Archive Site
  • cardiac index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • systemic vascular resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • pulmonary vascular resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • n-terminal pro-BNP concentration (serum) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • peak oxygen uptake (spiroergometric) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • dyspnoea symptoms / NYHA classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction
Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Coronary Heart Disease
Device: 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)
Other Name: Immunosorba
  • Active Comparator: 1
    Immunoadsorption with subsequent immunoglobulin substitution
    Intervention: Device: Immunoadsorption / Immunoglobulin substitution
  • No Intervention: 2

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Alexander Staudt, MD +49-3834-867322 staudt@uni-greifswald.de
Contact: Lars R Herda, MD +49-3834-866656 herda@uni-greifswald.de
Germany
 
NCT00738517
MPG 01/08
No
Dr. med. L. R. Herda, Ernst-Moritz-Arndt-Universität
University Medicine Greifswald
Fresenius Medical Care North America
Study Chair: Stephan B Felix, MD Ernst-Moritz-Arndt-Universität Greifswald
Study Director: Lars R Herda, MD Ernst-Moritz-Arndt-Universität Greifswald
Principal Investigator: Astrid Hummel, MD Ernst-Moritz-Arndt-Universität Greifswald
Principal Investigator: Marcus Doerr, MD Ernst-Moritz-Arndt-Universität Greifswald
Principal Investigator: Daniel Beug, MD Ernst-Moritz-Arndt-Universität Greifswald
University Medicine Greifswald
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP