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Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy

This study is currently recruiting participants.
Verified May 2013 by University Medicine Greifswald
Sponsor:
Collaborators:
Krupp von Bohlen und Halbach-Foundation, Essen, Germany
ENDI-Foundation, Bad Homburg, Germany
Bristol-Myers Squibb
Information provided by (Responsible Party):
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00558584
First received: November 14, 2007
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Dilated Cardiomyopathy
 Device: protein A immunoadsorption
Device: pseudo-immunoadsorption
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • Left ventricular ejection fraction (LVEF) at rest, as determined by contrast echocardiography [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • LVEF at rest, as determined by contrast echocardiography [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Reduction of brain natriuretic peptides (BNP and/or NT pro-BNP) [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Cardiopulmonary exercise capacity [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • LVEF at rest, as determined by magnetic resonance imaging (optional) [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Serious clinical adverse events [ Time Frame: day 7, 1 month, and 6 months ] [ Designated as safety issue: Yes ]
  • Quality of life (MLHFQ) [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dilated cardiomyopathy
  • LVEF <= 40% determined by contrast echocardiography
  • NYHA class II - IV
  • Age 18 - 65
  • Disease duration: symptomatic heart failure >1 year and <5 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
  • 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 echocardiography contrast agent (Luminity(R) according to Luminity(R) specifications, including cardiac shunts, pulmonary vascular compromise)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558584

Contacts
Contact: Stephan B Felix, MD + 49 3834 866656 felix@uni-greifswald.de
Contact: Alexander Staudt, MD + 49 3834 866656 staudt@uni-greifswald.de

Locations
Germany
Zentralklinik Bad Berka GmbH, Klinik für Kardiologie Recruiting
Bad Berka, Germany, 99437
Contact: Bernward Lauer, MD     +49 (0)36458 5-1201     kar@zentralklinik.de    
Kerckhoff-Klinik Forschungsgesellschaft mbH Recruiting
Bad Nauheim, Germany, 61231
Contact: Veselin Mitrovic, MD     +49 6032-996-2347     v.mitrovic@kerckhoff-klinik.de    
Principal Investigator: Veselin Mitrovic, MD            
Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Uwe Schulz, MD     +49 5731 97-2245     uschulz@hdz-nrw.de    
Herz- und Diabeteszentrums NRW Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Dieter Horstkotte, MD     +49 5731-97-1276     kaschmidt@hdz-nrw.de    
Principal Investigator: Dieter Horstkotte, MD            
Medizinische Klinik II, Kardiologie und Pulmologie, Charité, Universitätsmedizin Berlin, Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Uwe Kühl, MD, PhD     +49 30-8445-2343     uwe.kuehl@charite.de    
Principal Investigator: Uwe Kühl, MD, PhD            
Medizinische Klinik und Poliklinik, Kardiologie, Angiologie, Pneumologie , Charité, Universitätsmedizin Berlin, Campus Mitte Recruiting
Berlin, Germany, 10117
Contact: Fabian Knebel     +49 30-450 513 072     fabian.knebel@charite.de    
Principal Investigator: Fabian Knebel, MD            
German Heart Institute Berlin Services GmbH Recruiting
Berlin, Germany
Contact: Christoph Knosalla, MD     +49 30 4593 2087     knosalla@dhzb.de    
Principal Investigator: Christoph Knosalla, MD            
Medizinische Klinik und Poliklinik II, Universitätsklinkum Bonn Not yet recruiting
Bonn, Germany, 53105
Contact: Jörg Schwab, MD     +49 228 - 287-16670     joerg.schwab@ukb.uni-bonn.de    
Principal Investigator: Jörg Schwab, MD            
Klinik für Innere Medizin II und Nephrologie, Alfried Krupp von Bohlen und Halbach Krankenhaus gGmbH Recruiting
Essen, Germany, 45117
Contact: Wolfgang Grotz, MD     +49 -201-434-2545     wolfgang.grotz@krupp-krankenhaus.de    
Principal Investigator: Wolfgang Grotz, MD            
Klinik für Kardiologie, Westdeutsches Herzzentrum Essen, Universität Duisburg-Essen Recruiting
Essen, Germany, 45122
Contact: Raimund Erbel, MD     +49 201-723-4800     erbel@uni-essen.de    
Principal Investigator: Raimund Erbel, MD            
Klinik für Innere Medizin B, Universität Greifswald Recruiting
Greifswald, Germany, 17487
Contact: Marcus Dörr, MD     + 49 3834 866656     mdoerr@uni-greifswald.de    
Contact: Kathrin Mieske     +49 3834 866795     mieske@uni-greifswald.de    
Principal Investigator: Marcus Dörr, MD            
Abteilung Kardiologie und Pneumologie, Universität Göttingen - Bereich Humanmedizin Recruiting
Göttingen, Germany, 37075
Contact: Gerd Hasenfuß, MD     +49 551-39-6351        
Principal Investigator: Gerd Hasenfuß, MD            
Klinik und Poliklinik für Innere Medizin III, Universitätsklinikum Halle-Wittenberg Not yet recruiting
Halle (Saale), Germany, 06120
Contact: Michael Buerke, MD     +49 345-5572847     Michael.buerke@medizin.uni-halle.de    
Principal Investigator: Michael Buerke, MD            
Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herzzentrum Hamburg gGmbH Not yet recruiting
Hamburg, Germany, 20246
Contact: Angelika Costard-Jäckle, MD     +49 40 42803 3471        
Principal Investigator: Angelika Costard-Jäckle, MD            
Klinik für Innere Medizin III, Medizinische Universitätsklinik Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Hugo Katus, MD     +49 6221-56 - 86 70     hugo_katus@med.uni-heidelberg.de    
Principal Investigator: Hugo Katus, MD            
Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinik Homburg/Saar Recruiting
Homburg (Saar), Germany, 66421
Contact: NAdrea , MD     +49 6841 162 1202     link@med-in.uni-saarland.de    
Contact: Ingrid Kindermann, MD     +49 6841 162 1202     i.kindermann@med-in.uni-saarland.de    
Principal Investigator: Ingrid Kindermann, MD            
Klinik für Innere Medizin I, Universitätsklinikum Jena Recruiting
Jena, Germany, 07747
Contact: Hans-Reiner Figulla, MD     +49 3641-9324101     hans.figulla@med.uni-jena.de    
Principal Investigator: Hans-Reiner Figulla, MD            
Klinik III für Innere Medizin, Klinikum der Universität zu Köln Not yet recruiting
Köln, Germany, 50937
Contact: Markus Flesch     +49 221 478-5059     markus.flesch@uk-koeln.de    
Principal Investigator: Markus Flesch, MD            
Klinik für Innere Medizin/Kardiologie, Herzzentrum Leipzig GmbH Not yet recruiting
Leipzig, Germany, 04289
Contact: Gerhard Schuler, MD     +49 341-865-1428     schug@medizin.uni-leipzig.de    
Principal Investigator: Gerhard Schuler, MD            
Medizinische Klinik II, Universitätsklinikum Schleswig-Holstein, Campus Lübeck Recruiting
Lübeck, Germany, 23538
Contact: Joachim Weil, MD     + 49 0451 - 500 2501     joachim.weil@uk-sh.de    
Principal Investigator: Joachim Weil, MD            
Universitätsklinikum Magdeburg, Universitätsklinik für Kardiologie Recruiting
Magdeburg, Germany, 39120
Contact: Rüdiger C Braun-Dullaeus, MD     +49 391-67-13203     kkar@med.ovgu.de    
II. Medizinischen Klinik und Poliklinik, Johannes Gutenberg-Universität Mainz - Klinikum Not yet recruiting
Mainz, Germany, 55131
Contact: Thomas Münzel, MD     +49 6131-17-7250     muenzel@2-med.klinik.uni-mainz.de    
Principal Investigator: Thomas Münzel, MD            
Medizinische Klinik und Poliklinik C - Kardiologie und Angiologie, Universitätsklinikum Münster Not yet recruiting
Münster, Germany, 48149
Contact: Jörg Stypmann, MD     +49 251 8347621     Stypmann@mednet.uni-muenster.de    
Principal Investigator: Jörg Stypmann, MD            
Abteilung Kardiologie und Pulmologie, Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Udo Sechtem, MD     +49 711-8101 - 3456     udo.sechtem@rbk.de    
Principal Investigator: Udo Sechtem, MD            
Medizinische Klinik und Poliklinik, Abteilung Innere Medizin III, Medizinische Univ.-Klinik Tübingen Not yet recruiting
Tübingen, Germany, 72076
Contact: Meinrad Gawaz, MD     07071-298 3688     Meinrad.Gawaz@med.uni-tuebingen.de    
Principal Investigator: Meinrad Gawaz, MD            
Medizinische Klinik und Poliklinik I, Klinikum der Bayrischen Julius-Maximilians-Universität Not yet recruiting
Würzburg, Germany, 97080
Contact: Georg Ertl, MD     +49 931 201-36301     ertl_g@klinik.uni-wuerzburg.de    
Principal Investigator: Georg Ertl, MD            
Sweden
Department of Cardiology, Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, S-41345
Contact: Kristjan Karason, MD     +46 31 342 7554     Kristjan.Karason@medfak.gu.se    
Principal Investigator: Kristjan Karason, MD            
Sponsors and Collaborators
University Medicine Greifswald
Krupp von Bohlen und Halbach-Foundation, Essen, Germany
ENDI-Foundation, Bad Homburg, Germany
Bristol-Myers Squibb
Investigators
Principal Investigator: Stephan B Felix, MD Ernst-Moritz-Arndt University
  More Information

Additional Information:
Homepage: Department of Internal Medicine B, Ernst-Moritz-Arndt University, Greifswald, Germany  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT00558584     History of Changes
Other Study ID Numbers: IA-2006-001
Study First Received: November 14, 2007
Last Updated: May 14, 2013
Health Authority: Germany: Ethics Commission
Germany: German Institute of Medical Documentation and Information

Keywords provided by University Medicine Greifswald:
dilated cardiomyopathy
immunoadsorption
immunoglobulin G

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

ClinicalTrials.gov processed this record on May 23, 2013