Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction

May 10, 2016 updated by: University Medicine Greifswald

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • MV
      • Greifswald, MV, Germany, 17475
        • Ernst-Moritz-Arndt-Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
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 Names:
  • Immunosorba

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
left-ventricular ejection fraction as measured by echocardiography
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPG 01/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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