Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04654988
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2020-12-03
Brief Title:
Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy of Immunosuppression in Biopsy-proven Virus Negative Myocarditis or Inflammatory Cardiomyopathy
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE-MC
Brief Summary:
Myocarditis can result in numerous complications but there is paucity of data regarding optimal therapy short- and long-term effects of possibly effective immunosuppressive therapy The IMPROVE-MC study will provide high-quality scientific data about efficacy and safety of immunosuppressive therapy non-invasive MRI biomarkers and invasive diagnostics tests endomyocardial biopsy and prognosis in myocarditis The objective of this multicenter prospective randomized double-blind placebo-controlled trial is to assess the efficacy and safety of 12 - month treatment with prednisone and azathioprine comparing to placebo on top of guideline-recommended medical therapy in patients with biopsy-proven virus negative myocarditis or inflammatory cardiomyopathy and reduced ejection fraction LVEF 45 The study will also assess persistence of the treatment effects after 12 months
Detailed Description:
Myocarditis inflammatory cardiomyopathy which often leads to heart failure HF is still an under-studied disease with various clinical manifestations The active myocarditis is found post-mortem even in 42 of sudden deaths of young people and in 9-16 of adults and 46 of children with idiopathic dilated cardiomyopathy Moreover an increase in morbidity and mortality from myocarditis was recorded in the years 1990-2015 Myocarditis significantly increases the risk of HF serious arrhythmias and conduction abnormalities sudden death anxiety depression and it reduces quality of life Myocarditis affects mainly young people 18-40 years old and children who lead active family life and work Therefore the disease causes deterioration of entire family life it reduces individual productivity creates high and long-term treatment costs There is an urgent need to improve myocarditis therapy Current guidelines recommendations in myocarditis consists of standard treatment of already developed HF and long-term avoidance of physical activity Due to the lack of good quality scientific data there is no clear recommendation for the targeted treatment - thus patients prognosis may be poor The pathogenesis of myocarditis and limited reports suggest the reasonable chance of significant improvement of patients survival due to immunosuppressive therapy
Aim Aim of the IMPROVE-MC study is to assess the efficacy and safety of 12-month immunosuppressive treatment with prednisone and azathioprine compared with placebo on the guideline-recommended medical therapy in patients with biopsy-proven virus-negative myocarditis or inflammatory cardiomyopathy Secondary aim is to create ready-to-use diagnostic and therapeutic scheme in polish and international healthcare systems which can lead to myocarditis guidelines change
Population and methods In this multicenter 7 recruitment centers prospective randomized double-blind placebo-controlled trial we are going to include 100 patients aged 18-65 years old with biopsy-proven virus-negative myocarditis in stable or worsening course of the disease despite standard medical treatment with left ventricular ejection fraction LVEF 45 andor significant cardiac arrhythmias refractory to antiarrhythmic treatment
Exclusion criteria consist of ie another specific etiology of HF different from myocarditis already implanted ventricular assist device a heart transplant recipient contraindications to immunosuppressive treatment suspected sarcoidosis or giant cell myocarditis
Intervention azathioprine for 12 months and prednisone for the first 6 months versus placebo for 12 months Study course after randomization patients will undergo one-year double-blind treatment and then one-year follow-up to assess the long-term effects of the treatment
The efficacy and safety of the treatment will be assessed during study visits investigational products placebo will be provided and additional tests will be performed - 48-hour Holter monitoring echocardiography cardiac magnetic resonance imaging CMR laboratory tests and follow-up endomyocardial biopsy EMB after one-year of treatment In order to broaden knowledge about myocarditis pathogenesis additional genetic immunology and proteomic tests will be performed All echo MRI Holter and biopsy tests will be evaluated centrally
Study endpoints
primary endpoint is LVEF at 12-months secondary endpoints include analysis of eg clinical outcomes echocardiography CMR EMB laboratory examinations quality of life and heart failure questionnaires
Aim Aim of the IMPROVE-MC study is to assess the efficacy and safety of 12-month immunosuppressive treatment with prednisone and azathioprine compared with placebo on the guideline-recommended medical therapy in patients with biopsy-proven virus-negative myocarditis or inflammatory cardiomyopathy Secondary aim is to create ready-to-use diagnostic and therapeutic scheme in polish and international healthcare systems which can lead to myocarditis guidelines change
Population and methods In this multicenter 7 recruitment centers prospective randomized double-blind placebo-controlled trial we are going to include 100 patients aged 18-65 years old with biopsy-proven virus-negative myocarditis in stable or worsening course of the disease despite standard medical treatment with left ventricular ejection fraction LVEF 45 andor significant cardiac arrhythmias refractory to antiarrhythmic treatment
Exclusion criteria consist of ie another specific etiology of HF different from myocarditis already implanted ventricular assist device a heart transplant recipient contraindications to immunosuppressive treatment suspected sarcoidosis or giant cell myocarditis
Intervention azathioprine for 12 months and prednisone for the first 6 months versus placebo for 12 months Study course after randomization patients will undergo one-year double-blind treatment and then one-year follow-up to assess the long-term effects of the treatment
The efficacy and safety of the treatment will be assessed during study visits investigational products placebo will be provided and additional tests will be performed - 48-hour Holter monitoring echocardiography cardiac magnetic resonance imaging CMR laboratory tests and follow-up endomyocardial biopsy EMB after one-year of treatment In order to broaden knowledge about myocarditis pathogenesis additional genetic immunology and proteomic tests will be performed All echo MRI Holter and biopsy tests will be evaluated centrally
Study endpoints
primary endpoint is LVEF at 12-months secondary endpoints include analysis of eg clinical outcomes echocardiography CMR EMB laboratory examinations quality of life and heart failure questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003877-23 | EUDRACT_NUMBER | None | None |