Condition: Acute Myocarditis · Sponsor: University Hospital, Antwerp
The goal of this clinical trial is to demonstrate the efficacy of pulsed intravenous methylprednisolone in a single-blind randomized controlled trial versus standard therapy in patients with acute myocarditis and a mildly reduced LVEF. The main question\[s\] it aims to answer are: * is there an increase in LVEF (≥55% or an absolute increase in LVEF ≥ 10%) on echocardiogram after 5 days from randomization in patients treated with pulsed corticosteroid therapy vs. standard therapy? * is there a reduction in the proportion of patients with LVEF \< 55% AND/OR LV dilation on a 6-month CMRI in patients treated pulsed corticosteroid therapy vs. standard therapy? * To assess the effect of corticosteroids on the occurrence of the combined endpoint(1) all-cause death or (2) HTx or (3) long-term LVAD implant or (4) first rehospitalization due to HF or ventricular arrhythmias, or advanced AV block. Participants will be randomized in two arms in a 1:1 ratio. The experimental group will receive pulsed corticosteroid therapy on top of the standard therapy and patients in the placebo group will be treated with a saline solution on top of their standard therapy. All other tests are executed according to standard of care.
This description comes directly from the study's public registry record.
Caroline Van De Heyning, MD PhD · +32 821 3538 · caroline.vandeheyning@uza.be
Nicole Sturkenboom, MD · +32 821 3538 · nicole.sturkenboom@uza.be
Always discuss trial participation with your own doctor first.
| Antwerp University Hospital | Edegem, Antwerp, Belgium | Recruiting |
| Onze-Lieve-Vrouwziekenhuis (OLV ziekenhuis) | Aalst, Belgium | Recruiting |
| Middelheim Ziekenhuis | Antwerp, Belgium | Recruiting |
| Jessa ziekenhuis | Hasselt, Belgium | Recruiting |
| Universitair ziekenhuis Leuven | Leuven, Belgium | Recruiting |
| Niguarda Hospital | Milan, Milan, Italy | Recruiting |
| Azienda USL Toscane SUD Est | Arezzo, Italy | Not Yet Recruiting |
| Azienda Ospedaliera Papa Giovanni XXIII | Bergamo, Italy | Not Yet Recruiting |
| ASST Spedali Civili di Brescia | Brescia, Italy | Not Yet Recruiting |
| Careggi University Hospital | Florence, Italy | Not Yet Recruiting |
| Alessandro Manzoni hospital | Lecco, Italy | Not Yet Recruiting |
| San Raffaele Hospital | Milan, Italy | Not Yet Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05974462