Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction

NCT00738517 | Withdrawn Phase 1

• 1 other identifier: MPG 01/08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Coronary Heart Disease

Keywords

heart failure; coronary heart disease; autoantibodies; immunoadsorption; immunoglobulin substitution

Outcome Measures

Primary Outcomes (1)

• left-ventricular ejection fraction as measured by echocardiography

  6 months

Secondary Outcomes (6)

• cardiac index

  6 months

• systemic vascular resistance

  6 months

• pulmonary vascular resistance

  6 months

• n-terminal pro-BNP concentration (serum)

  6 months

• peak oxygen uptake (spiroergometric)

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Immunoadsorption with subsequent immunoglobulin substitution

Device: Immunoadsorption / Immunoglobulin substitution

2

NO INTERVENTION

Interventions

Immunoadsorption / Immunoglobulin substitution DEVICE

Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)

Also known as: Immunosorba

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Fresenius Medical Care North America: collaborator

Study Sites (1)

Ernst-Moritz-Arndt-Universität

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Related Publications (5)

• 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. doi: 10.1161/01.cir.99.5.649.

  PMID: 9950662 BACKGROUND

• 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. doi: 10.1038/nm955. Epub 2003 Nov 2.

  PMID: 14595408 BACKGROUND

• Dorffel 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. doi: 10.1161/01.cir.95.8.1994.

  PMID: 9133505 BACKGROUND

• Felix SB, Staudt A, Dorffel WV, Stangl V, Merkel K, Pohl M, Docke 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. doi: 10.1016/s0735-1097(00)00568-4.

  PMID: 10807465 BACKGROUND

• Staudt A, Schaper F, Stangl V, Plagemann A, Bohm 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. doi: 10.1161/01.cir.103.22.2681.

  PMID: 11390337 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Coronary Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases

Study Officials

• Stephan B Felix, MD

  University Medicine Greifswald

  STUDY CHAIR

• Lars R Herda, MD

  University Medicine Greifswald

  STUDY DIRECTOR

• Astrid Hummel, MD

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

• Marcus Doerr, MD

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

• Daniel Beug, MD

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

DE (1)