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Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction

This study has been withdrawn prior to enrollment.
(PI left center)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738517
First Posted: August 20, 2008
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fresenius Medical Care North America
Information provided by:
University Medicine Greifswald
  Purpose
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.

Condition Intervention Phase
Heart Failure Coronary Heart Disease Device: Immunoadsorption / Immunoglobulin substitution Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunoadsorption With Subsequent Immunoglobulin Substitution for Patients With Heart Failure After Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • left-ventricular ejection fraction as measured by echocardiography [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • cardiac index [ Time Frame: 6 months ]
  • systemic vascular resistance [ Time Frame: 6 months ]
  • pulmonary vascular resistance [ Time Frame: 6 months ]
  • n-terminal pro-BNP concentration (serum) [ Time Frame: 6 months ]
  • peak oxygen uptake (spiroergometric) [ Time Frame: 6 months ]
  • dyspnoea symptoms / NYHA classification [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Immunoadsorption with subsequent immunoglobulin substitution
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
No Intervention: 2

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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738517


Locations
Germany
Ernst-Moritz-Arndt-Universität
Greifswald, MV, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
Fresenius Medical Care North America
Investigators
Study Chair: Stephan B Felix, MD University Medicine Greifswald
Study Director: Lars R Herda, MD University Medicine Greifswald
Principal Investigator: Astrid Hummel, MD University Medicine Greifswald
Principal Investigator: Marcus Doerr, MD University Medicine Greifswald
Principal Investigator: Daniel Beug, MD University Medicine Greifswald
  More Information

Publications:
Responsible Party: Dr. med. L. R. Herda, Ernst-Moritz-Arndt-Universität
ClinicalTrials.gov Identifier: NCT00738517     History of Changes
Other Study ID Numbers: MPG 01/08
First Submitted: August 18, 2008
First Posted: August 20, 2008
Last Update Posted: May 11, 2016
Last Verified: May 2016

Keywords provided by University Medicine Greifswald:
heart failure
coronary heart disease
autoantibodies
immunoadsorption
immunoglobulin substitution

Additional relevant MeSH terms:
Heart Failure
Infarction
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs