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RecruitingPhase 4NCT04654988

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Immunosuppression in Biopsy-proven Virus Negative Myocarditis or Inflammatory Cardiomyopathy

Sponsor

Medical University of Warsaw

Enrollment

100 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Heart FailureMyocarditisImmunosuppressionEndomyocardial BiopsyCardiomyopathies, Secondary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial (called IMPROVE-MC) tests whether immunosuppressive therapy — medications that reduce immune system activity — can help people with myocarditis or inflammatory cardiomyopathy (conditions where the heart muscle becomes inflamed, leading to poor heart function). **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with (or are suspected of having) myocarditis or inflammatory cardiomyopathy, confirmed or to be confirmed via a heart tissue biopsy and cardiac MRI - Women must be using effective contraception or be postmenopausal **You may NOT be eligible if...** - Your heart inflammation is thought to be caused by a drug reaction, autoimmune condition that requires specific other treatments, or certain infections - You are pregnant or breastfeeding - You have significant uncontrolled health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrednisone

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

DRUGAzathioprine

Azathioprine: 2 mg/kg daily for 12 months

DRUGPlacebo Prednisone

Placebo Prednisone

DRUGPlacebo Azathioprine

Placebo Azathioprine

Locations(1)

First Department of Cardiology, Medical University of Warsaw

Warsaw, Poland

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NCT04654988

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