Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.

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.

Conditions

• Myocarditis
• Heart Failure
• Endomyocardial Biopsy
• Cardiomyopathies, Secondary
• Immunosuppression

Interventions

DRUG

Prednisone

Prednisone: 1 mg/kg daily for 4 weeks followed by gradually tapered dose for 5 months

DRUG

Azathioprine

Azathioprine: 2 mg/kg daily for 12 months

DRUG

Placebo Prednisone

Placebo Prednisone

DRUG

Placebo Azathioprine

Placebo Azathioprine

Sponsors & Collaborators

• Medical University of Warsaw

  lead OTHER

Principal Investigators

• Marcin Grabowski, Professor · Medical University of Warsaw

• Krzysztof Ozierański, MD, PhD · Medical University of Warsaw

• Agata Tymińska, MD, PhD · Medical University of Warsaw

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2027-09-30

Completion

2028-03-30

Countries

• Poland

Study Locations