Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy (NCT00558584) | Clinical Trial Compass
CompletedNot Applicable
Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy
Germany180 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range18 Years ā 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Dilated cardiomyopathy
* LVEF \<= 40% determined by contrast echocardiography
* NYHA class II - IV
* Age 18 - 70
* Disease duration: symptomatic heart failure ā„ 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, ā„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 immunosuā¦
What they're measuring
1
Left ventricular ejection fraction (LVEF) at rest, as determined by contrast echocardiography