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 range
18 Years – 70 Years
Sex
ALL
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 ≥ 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 immunosu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Left ventricular ejection fraction (LVEF) at rest, as determined by contrast echocardiography