Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522100
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Corticoid Therapy in Acute Myocarditis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Glucocorticoids Therapy in Acute Myocarditis With Severe Left Ventricular Dysfunction a Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COTAM
Brief Summary:
Refer to the Detailed Description section
Detailed Description:
Introduction Acute myocarditis AM is an inflammatory disease of the heart The incidence is approximately 22 out of 100 000 patients annually Clinically it ranges from subclinical pauci-symptomatic forms to life-threatening arrhythmias cardiogenic shock and sudden cardiac death In approximately more than 70 of cases AM resolves spontaneously In the remaining patients it evolves to a poor prognosis with left ventricular dilatation reduced cardiac contractility and progression to chronic heart failure
Complicated AM is defined as an AM with Left Ventricular Ejection Fraction LVEF 50 andor a sustained ventricular arrhythmia andor a hemodynamic instability Complicated AM is often associated with a poor prognosis in example risk of heart transplantation of 104 at 30 days and 147 at 5-year follow up whereas uncomplicated AM have none
Administration of immunosuppressive treatment IT is still debated According to experts consensus immunosuppressive treatment should be considered in complicated AM and should be used in recommended in case of fulminant myocarditis acute myocarditis with a presentation of cardiogenic shock ventricular arrhythmias or multiorgan system failure Nevertheless there is no data on use of glucocorticoids GC in complicated AM
Early application of high dose of GC in AM can control the cytokine storm and the inflammatory response rather than suppressing the overall immune response Best timing for their administration remains unknown The aim of this multicenter controlled randomized study is to demonstrate the benefit of high dose of GC therapy on mortality and cardiac events in patients with AM and left ventricular LV dysfunction
HypothesisObjective The main objective is to evaluate in patients with acute myocarditis with left-ventricular dysfunction the efficacy of a pulse of Methylprednisolone IV for 3 days at diagnosis followed by Prednisone per os versus placebo IV followed by placebo per os in association with conventional Heart Failure HF therapy on the occurrence of Major Cardiovascular Events MACE andor persistence of left ventricular dysfunction defined as LVEF 50 andor Global Longitudinal Strain GLS -16 between baseline and at 6 months
The primary endpoint is the Major Cardiovascular Events MACE andor persistence of left ventricular dysfunction defined as LVEF 50 andor Global Longitudinal Strain GLS - 16 between baseline D-2 and 6 months M6 follow up MACE is a combined criterion that includes all-cause mortality heart failure hospitalization sustained ventricular arrhythmia heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction at 6 months
Method Phase III prospective randomized placebo controlled superiority double blinded trial with 2 parallel groups randomized in a 11 ratio
Experimental group Methylprednisolone IV for 3 days followed by Prednisone per os conventional HF treatment
Control group placebo of Methylprednisolone IV followed by placebo of Prednisone per os conventional HF treatment
Complicated AM is defined as an AM with Left Ventricular Ejection Fraction LVEF 50 andor a sustained ventricular arrhythmia andor a hemodynamic instability Complicated AM is often associated with a poor prognosis in example risk of heart transplantation of 104 at 30 days and 147 at 5-year follow up whereas uncomplicated AM have none
Administration of immunosuppressive treatment IT is still debated According to experts consensus immunosuppressive treatment should be considered in complicated AM and should be used in recommended in case of fulminant myocarditis acute myocarditis with a presentation of cardiogenic shock ventricular arrhythmias or multiorgan system failure Nevertheless there is no data on use of glucocorticoids GC in complicated AM
Early application of high dose of GC in AM can control the cytokine storm and the inflammatory response rather than suppressing the overall immune response Best timing for their administration remains unknown The aim of this multicenter controlled randomized study is to demonstrate the benefit of high dose of GC therapy on mortality and cardiac events in patients with AM and left ventricular LV dysfunction
HypothesisObjective The main objective is to evaluate in patients with acute myocarditis with left-ventricular dysfunction the efficacy of a pulse of Methylprednisolone IV for 3 days at diagnosis followed by Prednisone per os versus placebo IV followed by placebo per os in association with conventional Heart Failure HF therapy on the occurrence of Major Cardiovascular Events MACE andor persistence of left ventricular dysfunction defined as LVEF 50 andor Global Longitudinal Strain GLS -16 between baseline and at 6 months
The primary endpoint is the Major Cardiovascular Events MACE andor persistence of left ventricular dysfunction defined as LVEF 50 andor Global Longitudinal Strain GLS - 16 between baseline D-2 and 6 months M6 follow up MACE is a combined criterion that includes all-cause mortality heart failure hospitalization sustained ventricular arrhythmia heart transplantation or assistance and recurrent acute myocarditis with LV dysfunction at 6 months
Method Phase III prospective randomized placebo controlled superiority double blinded trial with 2 parallel groups randomized in a 11 ratio
Experimental group Methylprednisolone IV for 3 days followed by Prednisone per os conventional HF treatment
Control group placebo of Methylprednisolone IV followed by placebo of Prednisone per os conventional HF treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None