The IASO-DCM trial is designed to randomize 200 patients with dilated cardiomyopathy to evaluate whether immunoadsorption with IgG substitution improves left ventricular ejection fraction at 6 months.
RCT (n=200)
Double-blind
1:1
Yes
Does immunoadsorption with subsequent IgG substitution improve left ventricular ejection fraction in patients with heart failure due to dilated cardiomyopathy?
The IASO-DCM trial will provide randomized, double-blind data on whether immunoadsorption with IgG substitution improves left ventricular function in patients with dilated cardiomyopathy.
AIMS: Pilot studies indicate that immunoadsorption with subsequent IgG substitution (IA/IgG) induces beneficial effects in patients with dilated cardiomyopathy (DCM) and heart failure. This placebo-controlled study investigates whether IA/IgG treatment enhances left ventricular (LV) systolic function as compared to a control group receiving pseudo-treatment. METHODS: This multicentre, randomized, double-blind, parallel-group trial aims to include 200 patients with heart failure due to DCM (LV ejection fraction LVEF <40%) on optimized guideline-directed heart failure medication. Participants are randomly assigned in a 1:1 ratio to IA/IgG using protein-A columns, or to pseudo-immunoadsorption followed by an intravenous infusion without IgG. Follow-up visits take place by telephone after 1 and 3 months and at the study centres after 6, 12 and 24 months. The primary efficacy endpoint is the change in LVEF from baseline to 6 months determined by contrast echocardiography, analysed at a core lab. In addition, LV end-diastolic and end-systolic volumes will be analysed as secondary endpoints over the entire study period to assess whether IA/IgG affects LV remodelling. As main secondary outcome, a composite of all-cause death, cardiac resuscitation, hospitalization for heart failure, and need for cardiac surgery to improve myocardial pump function will be evaluated after 24 months. In addition, exploratory outcomes as well as safety endpoints related to the treatment will be assessed throughout the whole study period. CONCLUSION: IASO-DCM is a randomized study which will provide comprehensive insights into the effects of immunoadsorption with subsequent IgG substitution in patients with DCM.
Dörr et al. (Wed,) conducted a rct in Dilated cardiomyopathy and heart failure (n=200). Immunoadsorption with subsequent IgG substitution (IA/IgG) vs. Pseudo-immunoadsorption followed by an intravenous infusion without IgG was evaluated on Change in LVEF from baseline to 6 months determined by contrast echocardiography. The IASO-DCM trial is designed to randomize 200 patients with dilated cardiomyopathy to evaluate whether immunoadsorption with IgG substitution improves left ventricular ejection fraction at 6 months.
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