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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738517

Contacts
Contact: Alexander Staudt, MD +49-3834-867322 staudt@uni-greifswald.de
Contact: Lars R Herda, MD +49-3834-866656 herda@uni-greifswald.de

Locations
Germany
Ernst-Moritz-Arndt-Universität Recruiting
Greifswald, MV, Germany, 17475
Contact: Alexander Staudt, MD    +49-3834-867322    staudt@uni-greifswald.de   
Contact: Lars R Herda, MD    +49-3834-866656    herda@uni-greifswald.de   
Principal Investigator: Lars R Herda, MD         
Principal Investigator: Astrid Hummel, MD         
Principal Investigator: Daniel Beug, MD         
Principal Investigator: Marcus Doerr, MD         
Principal Investigator: Joerg Ruppert, MD         
Sponsors and Collaborators
University Medicine Greifswald
Fresenius Medical Care North America
Investigators
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
  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
Study First Received: August 18, 2008
Last Updated: June 17, 2010
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on September 22, 2014