Clin2
NCT04654988Possibly a fitRecruiting

Immunosuppression study for active myocarditis or inflammatory cardiomyopathy

MyocarditisHeart FailureEndomyocardial BiopsyCardiomyopathies, SecondaryImmunosuppression

Treatments studied

Part of Heart & circulation clinical trials.

This Phase 4 study tests whether weakening the immune system (immunosuppression) works better for people with active myocarditis or inflammatory cardiomyopathy. It includes extra heart tests—two heart muscle biopsies and two heart MRI scans—to confirm the diagnosis and guide treatment.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 4
Enrollment
100 people
Ages
18 years to 65 years
Study type
Interventional

Who can take part

  • Be able to sign consent for the study tests, including two heart muscle biopsies (EMB) and two heart MRIs (CMR).
  • Be between 18 and 65 years old (and follow pregnancy-prevention rules if you can become pregnant).
  • Have clinically suspected or already diagnosed active myocarditis/inflammatory cardiomyopathy, and be able to undergo the biopsy during screening (or have had one recently).
  • Have heart pumping function measured during screening: LVEF between 10% and 45% on echocardiogram (ultrasound of the heart).
  • Have biopsy evidence of active inflammation (lymphocytic or eosinophilic) and a negative test for certain heart-infecting viruses in the biopsy tissue.
  • Be well enough to take the study medicines (steroids and/or azathioprine) with no major reasons you can’t, and not have active infections like HIV, hepatitis B, or hepatitis C.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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