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

History of Changes

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:

MedlinePlus related topics: Coronary Artery Disease Heart Attack Heart Diseases Heart Failure

U.S. FDA Resources

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

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:

Jahns R, Boivin V, Siegmund C, Inselmann G, Lohse MJ, Boege F. Autoantibodies activating human beta1-adrenergic receptors are associated with reduced cardiac function in chronic heart failure. Circulation. 1999 Feb 9;99(5):649-54.

Okazaki T, Tanaka Y, Nishio R, Mitsuiye T, Mizoguchi A, Wang J, Ishida M, Hiai H, Matsumori A, Minato N, Honjo T. Autoantibodies against cardiac troponin I are responsible for dilated cardiomyopathy in PD-1-deficient mice. Nat Med. 2003 Dec;9(12):1477-83. Epub 2003 Nov 2.

Dörffel WV, Felix SB, Wallukat G, Brehme S, Bestvater K, Hofmann T, Kleber FX, Baumann G, Reinke P. Short-term hemodynamic effects of immunoadsorption in dilated cardiomyopathy. Circulation. 1997 Apr 15;95(8):1994-7.

Felix SB, Staudt A, Dörffel WV, Stangl V, Merkel K, Pohl M, Döcke WD, Morgera S, Neumayer HH, Wernecke KD, Wallukat G, Stangl K, Baumann G. Hemodynamic effects of immunoadsorption and subsequent immunoglobulin substitution in dilated cardiomyopathy: three-month results from a randomized study. J Am Coll Cardiol. 2000 May;35(6):1590-8.

Staudt A, Schäper F, Stangl V, Plagemann A, Böhm M, Merkel K, Wallukat G, Wernecke KD, Stangl K, Baumann G, Felix SB. Immunohistological changes in dilated cardiomyopathy induced by immunoadsorption therapy and subsequent immunoglobulin substitution. Circulation. 2001 Jun 5;103(22):2681-6.

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:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Failure
Infarction
Myocardial Infarction
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013

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