Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00558584
Recruitment Status : Recruiting
First Posted : November 15, 2007
Last Update Posted : May 12, 2017
Krupp von Bohlen und Halbach-Foundation, Essen, Germany
ENDI-Foundation, Bad Homburg, Germany
Bristol-Myers Squibb
Information provided by (Responsible Party):
University Medicine Greifswald

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.

Condition or disease Intervention/treatment
Dilated Cardiomyopathy Device: protein A immunoadsorption Device: pseudo-immunoadsorption

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre, Randomized, Double-blind, Prospective Investigation on the Effects of Immunoadsorption on Cardiac Function in Patients With Dilated Cardiomyopathy
Study Start Date : December 2007
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: IA/IgG group
immunoadsorption using IA columns and subsequent IgG substitution
Device: protein A immunoadsorption
protein-A immunoadsorption and i.v. IgG substitution
Placebo Comparator: control group
pseudo-immunoadsorption followed by an intravenous infusion without IgG
Device: pseudo-immunoadsorption
pseudo-immunoadsorption followed by an intravenous infusion without IgG

Primary Outcome Measures :
  1. Left ventricular ejection fraction (LVEF) at rest, as determined by contrast echocardiography [ Time Frame: six months ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: 24 months ]
  2. LVEF at rest, as determined by contrast echocardiography [ Time Frame: 12 and 24 months ]
  3. Reduction of brain natriuretic peptides (BNP and/or NT pro-BNP) [ Time Frame: 6, 12, and 24 months ]
  4. Cardiopulmonary exercise capacity [ Time Frame: 6, 12, and 24 months ]
  5. LVEF at rest, as determined by magnetic resonance imaging (optional) [ Time Frame: 6, 12, and 24 months ]
  6. Serious clinical adverse events [ Time Frame: day 7, 1 month, and 6 months ]
  7. Quality of life (MLHFQ) [ Time Frame: 6, 12, and 24 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Refusal of the patient to provide consent
  • Suspected poor capability to follow instructions and cooperate
  • Another life-threatening disease with poor prognosis (survival less than 2 years)
  • Participation in any other clinical study within less than 30 days prior to screening date
  • Previous treatments with IA or immunoglobulin
  • Contraindications for application of the echocardiography contrast agent used (in accordance to the product specification). [Amendment 8]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00558584

Contact: Stephan B Felix, MD + 49 3834 8680500
Contact: Alexander Staudt, MD + 49 385 5202550

Deutsches Herzzentrum München Recruiting
München, Bayern, Germany, 80636
Contact: Schunkert Heribert, MD    +49 89 21184019   
Principal Investigator: Schunkert Heribert, MD         
Medizinische Klinik und Poliklinik I (Campus Großhadern u. Campus Innenstadt) Recruiting
München, Bayern, Germany, 81377
Contact: Dirk Sibbing, MD    +49 89 440073028   
Principal Investigator: Dirk Sibbing, MD         
Zentralklinik Bad Berka GmbH, Klinik für Kardiologie Withdrawn
Bad Berka, Germany, 99437
Kerckhoff-Klinik Forschungsgesellschaft mbH Recruiting
Bad Nauheim, Germany, 61231
Contact: Veselin Mitrovic, MD    +49 6032-996-2347   
Principal Investigator: Veselin Mitrovic, MD         
Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie Terminated
Bad Oeynhausen, Germany, 32545
Herz- und Diabeteszentrums NRW Terminated
Bad Oeynhausen, Germany, 32545
Medizinische Klinik und Poliklinik, Kardiologie, Angiologie, Pneumologie , Charité, Universitätsmedizin Berlin, Campus Mitte Recruiting
Berlin, Germany, 10117
Contact: Fabian Knebel    +49 30-450 613 216   
Principal Investigator: Fabian Knebel, MD         
Kardiologie (CC11), Campus Virchow, Charité, Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Uwe Kühl, MD, PhD    +49 30 - 450-553741   
Principal Investigator: Uwe Kühl, MD, PhD         
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany
Contact: Christoph Knosalla, MD    +49 30 4593 2087   
Principal Investigator: Christoph Knosalla, MD         
Medizinische Klinik und Poliklinik II, Universitätsklinkum Bonn Recruiting
Bonn, Germany, 53105
Contact: Nikos Werner, MD    +49 228 - 287-16670   
Principal Investigator: Nikos Werner, MD         
Klinik für Kardiologie, Westdeutsches Herzzentrum Essen, Universität Duisburg-Essen Terminated
Essen, Germany, 45122
Klinik für Innere Medizin B, Universität Greifswald Recruiting
Greifswald, Germany, 17487
Contact: Marcus Dörr, MD    +49 3834 86-80510   
Contact: Daniel Beug, MD    +49 3834 86-80858   
Principal Investigator: Marcus Dörr, MD         
Abteilung Kardiologie und Pneumologie, Universität Göttingen - Bereich Humanmedizin Recruiting
Göttingen, Germany, 37075
Contact: Rolf Wachter, MD    +49 551-39-22624   
Principal Investigator: Rolf Wachter, MD         
Klinik für Innere Medizin III, Medizinische Universitätsklinik Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Andreas Dösch, MD    +49 6221-5639936   
Principal Investigator: Andreas Dösch, MD         
Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinik Homburg/Saar Recruiting
Homburg (Saar), Germany, 66421
Contact: Andreas Link, MD    +49 6841 162 1202   
Principal Investigator: Andreas Link, MD         
Klinik für Innere Medizin I, Universitätsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Michel Noutsias, MD    +49 3641-9324527   
Principal Investigator: Michel Noutsias, MD         
Universitätsklinikum Magdeburg, Universitätsklinik für Kardiologie Recruiting
Magdeburg, Germany, 39120
Contact: Rüdiger C Braun-Dullaeus, MD    +49 391-67-13203   
Principal Investigator: Rüdiger Braun-Dullaeus, MD         
Abteilung Kardiologie und Pulmologie, Robert-Bosch-Krankenhaus Terminated
Stuttgart, Germany, 70376
Medizinische Klinik und Poliklinik, Abteilung Innere Medizin III, Medizinische Univ.-Klinik Tübingen Terminated
Tübingen, Germany, 72076
Medizinische Klinik und Poliklinik I, Klinikum der Bayrischen Julius-Maximilians-Universität Recruiting
Würzburg, Germany, 97080
Contact: Bettina Kraus, MD    +49 931 201-46252   
Principal Investigator: Bettina Kraus, MD         
Internal Medicine - Cardiology, Belgrade University School of Medicine Recruiting
Belgrade, Serbia
Contact: Dragan Simic, MD    +38 111 361 4738   
Principal Investigator: Dragan Simic, MD         
Department of Cardiology, Sahlgrenska University Hospital Terminated
Göteborg, Sweden, S-41345
Sponsors and Collaborators
University Medicine Greifswald
Krupp von Bohlen und Halbach-Foundation, Essen, Germany
ENDI-Foundation, Bad Homburg, Germany
Bristol-Myers Squibb
Principal Investigator: Stephan B Felix, MD Ernst-Moritz-Arndt University

Additional Information:
Responsible Party: University Medicine Greifswald Identifier: NCT00558584     History of Changes
Other Study ID Numbers: IA-2006-001
First Posted: November 15, 2007    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by University Medicine Greifswald:
dilated cardiomyopathy
immunoglobulin G

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases