A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of immunosuppression in biopsy-proven virus-negative myocarditis or inflammatory cardiomyopathy (IMPROVE-MC).

Conditions

Myocarditis, inflammatory cardiomyopathy

Brief summary

LVEF at 12 – months.

Detailed description

Proportion of patients who responded to immunosuppressive therapy as defined by an LVEF increase of ≥ 10% over time., LVEF at 12 months in subgroups of patients with baseline LVEF ≤ 30% and > 30%, Change in the LV end-systolic and end-diastolic dimensions as well as the LV end-systolic and end-diastolic volumes over time., Change from baseline in NYHA class over time., Occurrence of adjudicated heart failure decompensation (hospitalization or ambulatory visit)., LVEF at 24 months (maintenance or further improvement)., LVEF at 24 months (maintenance or further improvement) in subgroups of patients with baseline LVEF ≤30% and >30%, Change in the LV end-systolic and end-diastolic dimensions as well as the LV end-systolic and end-diastolic volumes over time. (13-24 months), Change in NYHA class over time. (13-24 months), Occurrence of adjudicated heart failure decompensation (hospitalization or ambulatory visit). (13-24 months)

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGEncorton

DRUG5 mg

DRUGtabletki

DRUGPlacebo Encorton 10 mg

DRUGPlacebo Encorton 5 mg

DRUGAZATHIOPRINE VIS

DRUG50 mg

DRUGPlacebo Azathioprine

DRUG10 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
LVEF at 12 – months.	—

Secondary

Measure	Time frame
Proportion of patients who responded to immunosuppressive therapy as defined by an LVEF increase of ≥ 10% over time., LVEF at 12 months in subgroups of patients with baseline LVEF ≤ 30% and > 30%, Change in the LV end-systolic and end-diastolic dimensions as well as the LV end-systolic and end-diastolic volumes over time., Change from baseline in NYHA class over time., Occurrence of adjudicated heart failure decompensation (hospitalization or ambulatory visit)., LVEF at 24 months (maintenance or further improvement)., LVEF at 24 months (maintenance or further improvement) in subgroups of patients with baseline LVEF ≤30% and >30%, Change in the LV end-systolic and end-diastolic dimensions as well as the LV end-systolic and end-diastolic volumes over time. (13-24 months), Change in NYHA class over time. (13-24 months), Occurrence of adjudicated heart failure decompensation (hospitalization or ambulatory visit). (13-24 months)	—

Measure

Time frame

Proportion of patients who responded to immunosuppressive therapy as defined by an LVEF increase of ≥ 10% over time., LVEF at 12 months in subgroups of patients with baseline LVEF ≤ 30% and > 30%, Change in the LV end-systolic and end-diastolic dimensions as well as the LV end-systolic and end-diastolic volumes over time., Change from baseline in NYHA class over time., Occurrence of adjudicated heart failure decompensation (hospitalization or ambulatory visit)., LVEF at 24 months (maintenance or further improvement)., LVEF at 24 months (maintenance or further improvement) in subgroups of patients with baseline LVEF ≤30% and >30%, Change in the LV end-systolic and end-diastolic dimensions as well as the LV end-systolic and end-diastolic volumes over time. (13-24 months), Change in NYHA class over time. (13-24 months), Occurrence of adjudicated heart failure decompensation (hospitalization or ambulatory visit). (13-24 months)

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Countries

Poland

Outcome results

None listed