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April 14, 2014

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Eligibility NCT00558584 Dilated Cardiomyopathy


  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 65 Years
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.
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 < 2 years)
Participation in any other clinical study within < 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)