Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy

NCT00558584 | Completed DMC

• 1 other identifier: IA-2006-001
• Study Type: interventional
• Target: 180
• Locations: 2 countries
• Sites: 20

Brief Summary

The purpose of this study is to investigate the effects of immunoadsorption and subsequent IgG substitution in patients with dilated cardiomyopathy compared to a control group.

Conditions

Dilated Cardiomyopathy

Keywords

dilated cardiomyopathy; immunoadsorption; immunoglobulin G

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (LVEF) at rest, as determined by contrast echocardiography

  six months

Secondary Outcomes (7)

• Clinical outcome (non-cardiovascular death, cardiovascular death, sudden death, hospitalization for cardiovascular cause/heart failure, acute myocardial infarction, unstable angina, stroke, cardiac interventions/procedures, clinical deterioration)

  24 months

• LVEF at rest, as determined by contrast echocardiography

  12 and 24 months

• Reduction of brain natriuretic peptides (BNP and/or NT pro-BNP)

  6, 12, and 24 months

• Cardiopulmonary exercise capacity

  6, 12, and 24 months

• LVEF at rest, as determined by magnetic resonance imaging (optional)

  6, 12, and 24 months

Study Arms (2)

IA/IgG group

ACTIVE COMPARATOR

immunoadsorption using IA columns and subsequent IgG substitution

Device: protein A immunoadsorption

control group

PLACEBO COMPARATOR

pseudo-immunoadsorption followed by an intravenous infusion without IgG

Device: pseudo-immunoadsorption

Interventions

protein A immunoadsorption DEVICE

protein-A immunoadsorption and i.v. IgG substitution

IA/IgG group

pseudo-immunoadsorption DEVICE

pseudo-immunoadsorption followed by an intravenous infusion without IgG

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dilated cardiomyopathy
• LVEF \<= 40% determined by contrast echocardiography
• NYHA class II - IV
• Age 18 - 70
• Disease duration: symptomatic heart failure ≥ 6 months and \<7 years prior to screening date
• Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers, and aldosterone antagonists (the latter at the discretion of the attending physician), for at least 6 months and at stable doses for at least 2 months prior to screening date.
• The patient's informed consent

You may not qualify if:

• NYHA class IV patients who are bed-ridden and dependent upon parenteral medication
• Cardiac insufficiency resulting from another basic disease (e.g. coronary artery disease, ≥50% stenosis of major vessel as ascertained by coronary angiography performed more recent than three years before screening date, hypertensive heart disease, or valvular defects \>second degree
• History of myocardial infarction
• Acute myocarditis according to Dallas criteria
• Endocrine disorder excluding insulin-dependent diabetes mellitus
• Implanted cardiac defibrillator (ICD) \<1 month before screening date
• Cardiac resynchronization therapy (CRT) \<6 months before screening date
• I.v. medication with inotropic drugs, vasodilators or repeated (\>1/day) i.v. administration of diuretics.
• Active infectious disease, or signs of ongoing infection with CRP \>10mmol/L
• Impaired renal function (serum creatinine \>220 µmol/L)
• Any disease requiring immunosuppressive drugs
• Anaemia (haemoglobin below 90 g/L) due to other causes than CHF
• Pregnancy or lactation, or childbearing potential without appropriate contraception
• Alcohol or drug abuse
• Presence of a malignant tumour, or remission of malignancy \< 5 years

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Krupp von Bohlen und Halbach-Foundation, Essen, Germany: collaborator
• ENDI-Foundation, Bad Homburg, Germany: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (21)

Deutsches Herzzentrum München

München, Bavaria, 80636, Germany

Location

Medizinische Klinik und Poliklinik I (Campus Großhadern u. Campus Innenstadt)

München, Bavaria, 81377, Germany

Location

Kerckhoff-Klinik Forschungsgesellschaft mbH

Bad Nauheim, 61231, Germany

Location

Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie

Bad Oeynhausen, 32545, Germany

Location

Herz- und Diabeteszentrums NRW

Bad Oeynhausen, 32545, Germany

Location

Medizinische Klinik und Poliklinik, Kardiologie, Angiologie, Pneumologie , Charité, Universitätsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany

Location

Kardiologie (CC11), Campus Virchow, Charité, Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Medizinische Klinik und Poliklinik II, Universitätsklinkum Bonn

Bonn, 53105, Germany

Location

Klinik für Kardiologie, Westdeutsches Herzzentrum Essen, Universität Duisburg-Essen

Essen, 45122, Germany

Location

Abteilung Kardiologie und Pneumologie, Universität Göttingen - Bereich Humanmedizin

Göttingen, 37075, Germany

Location

Klinik für Innere Medizin B, Universität Greifswald

Greifswald, 17487, Germany

Location

Klinik für Innere Medizin III, Medizinische Universitätsklinik Heidelberg

Heidelberg, 69120, Germany

Location

Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinik Homburg/Saar

Homburg (Saar), 66421, Germany

Location

Klinik für Innere Medizin I, Universitätsklinikum Jena

Jena, 07747, Germany

Location

Universitätsklinikum Magdeburg, Universitätsklinik für Kardiologie

Magdeburg, 39120, Germany

Location

Abteilung Kardiologie und Pulmologie, Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Medizinische Klinik und Poliklinik, Abteilung Innere Medizin III, Medizinische Univ.-Klinik Tübingen

Tübingen, 72076, Germany

Location

Medizinische Klinik und Poliklinik I, Klinikum der Bayrischen Julius-Maximilians-Universität

Würzburg, 97080, Germany

Location

Internal Medicine - Cardiology, Belgrade University School of Medicine

Belgrade, Serbia

Location

Department of Cardiology, Sahlgrenska University Hospital

Gothenburg, S-41345, Sweden

Location

Related Publications (5)

• Staudt A, Staudt Y, Dorr M, Bohm M, Knebel F, Hummel A, Wunderle L, Tiburcy M, Wernecke KD, Baumann G, Felix SB. Potential role of humoral immunity in cardiac dysfunction of patients suffering from dilated cardiomyopathy. J Am Coll Cardiol. 2004 Aug 18;44(4):829-36. doi: 10.1016/j.jacc.2004.04.055.

  PMID: 15312867 BACKGROUND

• Felix SB, Staudt A, Landsberger M, Grosse Y, Stangl V, Spielhagen T, Wallukat G, Wernecke KD, Baumann G, Stangl K. Removal of cardiodepressant antibodies in dilated cardiomyopathy by immunoadsorption. J Am Coll Cardiol. 2002 Feb 20;39(4):646-52. doi: 10.1016/s0735-1097(01)01794-6.

  PMID: 11849864 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

• Staudt A, Bohm M, Knebel F, Grosse Y, Bischoff C, Hummel A, Dahm JB, Borges A, Jochmann N, Wernecke KD, Wallukat G, Baumann G, Felix SB. Potential role of autoantibodies belonging to the immunoglobulin G-3 subclass in cardiac dysfunction among patients with dilated cardiomyopathy. Circulation. 2002 Nov 5;106(19):2448-53. doi: 10.1161/01.cir.0000036746.49449.64.

  PMID: 12417541 BACKGROUND

• Felix SB, Staudt A. Non-specific immunoadsorption in patients with dilated cardiomyopathy: mechanisms and clinical effects. Int J Cardiol. 2006 Sep 10;112(1):30-3. doi: 10.1016/j.ijcard.2006.05.014. Epub 2006 Jul 21.

  PMID: 16860418 BACKGROUND

Related Links

• Homepage: Department of Internal Medicine B, Ernst-Moritz-Arndt University, Greifswald, Germany

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Stephan B Felix, MD

  Ernst-Moritz-Arndt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2021
• Study Completion: April 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

DE (19); SE (1)