Actively Recruiting
Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.
Led by Medical University of Warsaw · Updated on 2024-03-28
100
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent including agreement to two endomyocardial biopsies and two cardiac MRIs
- Clinically suspected or biopsy-confirmed active myocarditis or inflammatory cardiomyopathy
- Men or women aged 18 to 65 years
- Women of childbearing potential must have negative pregnancy test and use reliable contraception or abstain
- No significant improvement or worsening heart condition despite standard therapy in last 3 months
- Left ventricular ejection fraction between 10% and 45% during screening
- Histological and immunohistochemical evidence of active myocarditis or inflammatory cardiomyopathy
- Absence of cardiotropic viruses in cardiac tissue by PCR
You will not qualify if you...
- Contraindications to immunosuppressive therapy including allergies, untreated infections, or uncontrolled medical conditions
- Active infections such as HIV, HBV, or HCV
- Other specific causes of heart failure like severe congenital or valvular disease
- Infiltrative, storage, genetic, or other specific cardiomyopathies
- Diagnosed or suspected cardiac sarcoidosis or giant cell myocarditis
- NYHA heart failure class I or IV
- Body mass index over 40 kg/m2 or body weight under 50 kg
- Pregnancy, lactation, or lack of consent to effective contraception
- Active or recent cancer within 5 years
- History of cytostatic therapy or radiotherapy
- Significant liver or kidney disease
- Implanted or planned ventricular assist devices, cardiac resynchronization therapy, or heart transplant
- Pacemaker or ICD requiring high ventricular pacing (>30%)
- Gastrointestinal disorders affecting drug absorption
- Life expectancy less than 3 years
- Contraindications or intolerance to cardiac MRI
- Recent immunization with live vaccines
- Chronic substance abuse or non-compliance
- Use of other investigational drugs within 30 days
- Involvement in study execution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Department of Cardiology, Medical University of Warsaw
Warsaw, Poland, 02-097
Actively Recruiting
Research Team
K
Krzysztof Ozierański, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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