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Trial record 18 of 164 for:    Idiopathic Dilated Cardiomyopathy

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.
 
ClinicalTrials.gov Identifier: NCT00558584
Recruitment Status : Recruiting
First Posted : November 15, 2007
Last Update Posted : July 2, 2018
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

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 Phase
Dilated Cardiomyopathy Device: protein A immunoadsorption Device: pseudo-immunoadsorption Not Applicable

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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 2019
Estimated Study Completion Date : December 2020


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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00558584


Contacts
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Contact: Stephan B Felix, MD + 49 3834 8680500 felix@uni-greifswald.de
Contact: Alexander Staudt, MD + 49 385 5202550 alexander.staudt@helios-kliniken.de

Locations
Show Show 22 study locations
Sponsors and Collaborators
University Medicine Greifswald
Krupp von Bohlen und Halbach-Foundation, Essen, Germany
ENDI-Foundation, Bad Homburg, Germany
Bristol-Myers Squibb
Investigators
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Principal Investigator: Stephan B Felix, MD Ernst-Moritz-Arndt University

Additional Information:
Publications:
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT00558584    
Other Study ID Numbers: IA-2006-001
First Posted: November 15, 2007    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Keywords provided by University Medicine Greifswald:
dilated cardiomyopathy
immunoadsorption
immunoglobulin G
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly