Heart failure & cardiomyopathies
Multicentre, Randomized, Double-Blind, Prospective Study on the Effects of ImmunoAdSorptiOn on Cardiac Function in Patients with Dilated CardioMyopathy (IASO-DCM): Rationale and Design
Study context
- Population
- Patients with HF due to dilated cardiomyopathy (DCM) (LVEF <40%) on optimised guideline-directed HF medicationplanned
- Participants
- 200 patients
- Planned comparison
- Immunoadsorption with subsequent IgG substitution vs pseudo-treatment
- Primary endpoint
- Change in LVEF by contrast echocardiography (core lab)
- Follow-up
- Baseline to 6 months
Methodological detailsrationale and design, multicentre, double-blind, placebo-controlled, parallel-group, 1:1 randomisation, Follow-up by telephone at 1 and 3 months and at study centres at 6, 12 and 24 months, Main secondary outcome: composite of all-cause death, cardiac resuscitation, HF hospitalisation and cardiac surgery to improve pump function at 24 months, Secondary: Left ventricular (LV) end-diastolic and end-systolic volumes over the study period
- Rationale and design
- Multicentre
- Double-blind
- Placebo-controlled
- Parallel-group
- 1:1 randomisation
- Follow-up by telephone at 1 and 3 months and at study centres at 6, 12 and 24 months
- Main secondary outcome: composite of all-cause death, cardiac resuscitation, HF hospitalisation and cardiac surgery to improve pump function at 24 months
- Secondary: LV end-diastolic and end-systolic volumes over the study period
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Multicentre, Randomized, Double-Blind, Prospective Study on the Effects of ImmunoAdSorptiOn on Cardiac Function in Patients with Dilated CardioMyopathy (IASO-DCM): Rationale and Design. Eur J Heart Fail. Published 2 October 2024. doi:10.
Summarised from the published abstract; every number is checked against it