Please use this identifier to cite or link to this item: http://dx.doi.org/10.25673/118303
Title: Multicentre, randomized, double-blind, prospective study on the effects of ImmunoAdSorptiOn on cardiac function in patients with Dilated CardioMyopathy (IASO-DCM) : rationale and design
Author(s): Dörr, MarcusLook up in the Integrated Authority File of the German National Library
Böhm, Michael
Erdmann, ErlandLook up in the Integrated Authority File of the German National Library
Groß, Stefan
Mahabadi, Amir AbbasLook up in the Integrated Authority File of the German National Library
Nauck, Matthias
Nickening, Georg
Schultheiss, Heinz-PeterLook up in the Integrated Authority File of the German National Library
Staudt, AlexanderLook up in the Integrated Authority File of the German National Library
Werdan, KarlLook up in the Integrated Authority File of the German National Library
Waagstein, FinnLook up in the Integrated Authority File of the German National Library
Hjalmarson, Åke
Felix, StephanLook up in the Integrated Authority File of the German National Library
Issue Date: 2024
Type: Article
Language: English
Abstract: 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.
URI: https://opendata.uni-halle.de//handle/1981185920/120262
http://dx.doi.org/10.25673/118303
Open Access: Open access publication
License: (CC BY-NC-ND 4.0) Creative Commons Attribution NonCommercial NoDerivatives 4.0(CC BY-NC-ND 4.0) Creative Commons Attribution NonCommercial NoDerivatives 4.0
Journal Title: European journal of heart failure
Publisher: Wiley
Publisher Place: Oxford
Volume: 26
Issue: 11
Original Publication: 10.1002/ejhf.3476
Page Start: 2464
Page End: 2473
Appears in Collections:Open Access Publikationen der MLU

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