Success in the competition for non-commercial clinical trials in the field of civilization diseases

16.02.2022

Prof. Leszek Kalinowski

The team of Prof. Leszek Kalinowski, Head of the Division of Medical Laboratory Diagnostics of the MUG, will receive 9 999 874.40 PLN of funding from the Medical Research Agency for the project Wpływ trimetazydyny na funkcję śródbłonka i biomarkery korelujące z rokowaniem w niewydolności serca z zachowaną frakcją wyrzutową (Impact of trimetazidine on endothelial function and biomarkers correlating with the prognosis of heart failure with preserved ejection fraction). The application received a high mark from the competition committee, which gave it a place among the three highest-rated projects. Co-financing in the ABM competition for non-commercial clinical trials in the field of civilization diseases was received by 10 projects for a total amount of PLN 97 799 026.02 PLN.

The main researcher of the project emphasizes that heart failure with a preserved ejection fraction (HFpEF) is a fairly common disease of civilization, which affects more than half of all patients with heart failure. Its incidence may increase rapidly in the near future, due to possible late cardiovascular complications reported in patients after COVID-19 infection. The main causes of disease development are chronic inflammation and excessive oxidative stress, which are often associated with the coexistence of civilization diseases (including hypertension, diabetes, obesity, dyslipidemia). Regarding the improvement of prognosis in terms of reducing mortality, there is no evidence to date of the effectiveness of any drug used in patients with HFpEF.

– The main research hypothesis is that trimetazidine, through its pleiotropic action, may have a positive effect on the parameters of inflammation and on endothelial and microcirculation functions, which may improve treatment outcomes in patients with HFpEF. The implementation of the study may contribute to establishing a new indication for trimetazidine and may improve the diagnostic scheme of patients with HFpEF – says Prof. Kalinowski.

As part of the project implementation, an eight-center, randomized, double-blind clinical trial was planned in Poland, involving 468 patients with HFpEF, in order to assess the effect of trimetazidine on a number of endpoints, such as all-cause mortality, cardiovascular mortality, hospitalization due to worsening heart failure, total number of hospitalizations, assessment of the patient’s fitness and risk of adverse events. The treatment period for patients would be 96 weeks.

– The project will involve the team and infrastructure of the Division of Medical Laboratory Diagnostics of the MUG, acting as the so-called node biobank in the Polish Biobanking Network (BBMRI.pl) in order to create a collection of samples and determine parameters in the biological material of patients – adds Prof. Kalinowski. – In addition, endothelial functions will be tested in cooperation with the MUG’s Center of Translational Medicine using non-invasive imaging methods LSCI and FMD, which allow the functional assessment of endothelial function and can be repeated during treatment monitoring.

Prof. Piotr Widłak

The Medical University of Gdańsk is one of the largest beneficiaries of MRA competitions supporting academic clinical trials. The university unit supporting all scientific initiatives in the form of clinical trials, including those carried out with national and international partners, is the “Clinical Research Support Centre” Office (CRSC), whose Director is Prof. Piotr Widłak.

– CRSC is consolidating the University’s activities aimed at developing paths to improve the quality of clinical trials and increasing the availability of patients to new therapies and treatment regimens. The task of the Center is to comprehensively support clinical trials conducted by the MUG, and ultimately also commercial clinical trials conducted by the University’s partners – explains Prof. Widłak.

Detailed information about the CRSC is available at www.clinicalresearch.mug.edu.pl.

photo Paweł Sudara/MUG