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NOT YET RECRUITING
NCT06522100
PHASE3

Corticoid Therapy in Acute Myocarditis

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Refer to the "Detailed Description" section.

Official title: Use of Glucocorticoids Therapy in Acute Myocarditis With Severe Left Ventricular Dysfunction: a Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2025-02-01

Completion Date

2028-08-16

Last Updated

2024-07-29

Healthy Volunteers

No

Interventions

DRUG

Intravenous administration of Methylprednisolone

Patients will take intravenous administration of Methylprednisolone (500mg/100ml by IV over 30 minutes per day) for 3 days.

DRUG

Oral Prednisone

After intravenous administration of Methylprednisolone patients will take by oral Prednisone 1mg/kg per day once a day (with a maximum dose of 90 mg per day for patients weighing \> 90kg) for 1 month, followed with a progressive decrease of 10 mg Prednisone every 15 days until a dose of 10mg per day during 15 days (= stop).

DRUG

Perfusion of placebo

Patients will take perfusion of placebo (G5%: 100ml over 30 minutes per day) for 3 days.

DRUG

Oral Prednisone placebo

After the perfusion of placebo, patients will take by oral Prednisone placebo once a day for the same duration as that required if the patient was in the investigational medicinal products group (1 month + progressive decrease).