Myocarditis: Will the Polish IMPROVE-MC study pave the way for global guidelines?
IMPROVE-MC demonstrates that Polish centers can conduct research that sets standards for clinical practice. If the results confirm the effectiveness of immunosuppression in patients with myocarditis, the door to changing clinical practice will remain wide open. Myocarditis affects people in their prime, limiting their lifespan and quality of life, and too often leaves physicians without evidence-based therapeutic options. A team from the Medical University of Warsaw is launching a project to fill this gap, adhering to the highest standards of clinical research.
Myocarditis and inflammatory cardiomyopathy can lead to severe heart failure or dangerous arrhythmias within weeks, limiting the lifespan and quality of life of these typically young, professionally active individuals. Despite advances in diagnostics , there are no therapies verified by highly credible research. The principal investigator, Prof. Marcin Grabowski, MD, PhD , leaves no doubt:
Confirming the efficacy and safety of immunosuppressive treatment in patients with myocarditis is fundamental, as it will allow for the world's first scientifically validated therapy, which could be included in international recommendations . Attempts to develop such a therapy have been ongoing for decades, but a multicenter, randomized, double-blind, placebo-controlled trial with adequate group homogeneity (strict inclusion criteria based on cardiac biopsy) and a large patient population have yet to be conducted. These are crucial parameters that indicate a quality clinical trial, from which conclusions can be drawn and global recommendations developed.
The project is being implemented by the Medical University of Warsaw , in collaboration with leading domestic and international centers; funding is provided by the Medical Research Agency . The study will enroll 100 patients aged 18–65 years with endomyocardial biopsy-confirmed virus-negative myocarditis and reduced left ventricular ejection fraction (≤45%) or significant, refractory arrhythmias. Participants are randomly assigned to immunosuppression (prednisone and azathioprine) or placebo , always in conjunction with standard therapy. Treatment lasts 12 months, followed by a one-year follow-up to assess the durability of effects.
One of the pillars of IMPROVE-MC quality is a rigorous definition of the population. As co-creator and project manager, Prof. Krzysztof Ozierański, MD, PhD, emphasizes:
Myocarditis is a histopathological diagnosis, so final diagnosis requires a heart biopsy, which is still very rarely performed in Poland. However, we continue to actively promote knowledge and the importance of heart biopsy indications and technical aspects, which results in a steadily increasing number of patients referred to our center for a complete and comprehensive diagnosis of non-ischemic cardiomyopathy.
This ensures that the inclusion criteria for IMPROVE-MC are both narrow and clinically precise. International partnerships and central core labs
See also:From the outset, the project was developed in collaboration with European leaders, including the University of Padua, co-authors of the only European document on the management of myocarditis. Seven renowned cardiology centers were involved in the study, and key assessments are centralized. Project co-principal investigator Agata Tymińska, MD, PhD, emphasizes the stability and quality of the protocol: " The project protocol was consulted with world leaders in the field of myocarditis, which allowed for the creation of a project that did not require substantive modification throughout its duration. " She adds: " Creating a central assessment in the so-called core labs crucial to the research project (echocardiogram, cardiac resonance imaging, laboratory tests, heart biopsy) allows for the most reliable results. "
The study's leader is Prof. Marcin Grabowski , Head of the 1st Department and Clinic of Cardiology at the Medical University of Warsaw , a cardiac implantation and biopsy surgeon, a spokesperson for the Polish Cardiac Society (PTK), and the author of over 200 publications. The team is co-founded by Dr. Agata Tymińska and Prof. Krzysztof Ozierański , cardiologists from the Medical University of Warsaw with European Cardiology Council (ESC) certification and extensive scientific achievements. Initial information about the project was published in the European Heart Journal , enhancing its international visibility. The intended outcome is a completed diagnostic and therapeutic regimen, which, if immunosuppression proves effective and safe, could be included in recommendations in Poland and internationally.
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IMPROVE-MC has the potential to fill the most serious gap in the treatment of myocarditis: the lack of proven, effective pharmacological intervention in a precisely diagnosed, virus-negative population. If primary endpoints confirm the superiority of immunosuppression over placebo, physicians will have an evidence-based tool, and patients will have a chance for a real improvement in their prognosis. It also provides the impetus for heart biopsy to become the standard diagnostic tool for difficult cardiomyopathies in Poland.
Updated: 23/09/2025 08:00
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