Havirov 1

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

This research aims to improve early detection of Hepatitis C virus (HCV) infection among people who inject drugs (PWID) in the Czech Republic. It is a national, prospective, multicenter, non-interventional pilot project conducted in 18 clinical centers. The goal is to prepare, implement, and evaluate a screening process for early HCV detection and to develop new methods to integrate this screening into social healthcare systems. The project also seeks to reduce further transmission of HCV by identifying gaps in ongoing care for this population. Participants will undergo testing for hepatitis C antibodies to determine past exposure to the virus. Those who test positive for antibodies will receive further testing for HCV RNA and genotype to confirm active infection. Approximately 3,000 PWID will be enrolled to test the screening procedure and assess its effectiveness in real-world clinical settings. Participants will be screened and monitored until December 31, 2025, with researchers tracking the incidence of HCV in the screened cohort. The study will help create a methodology for continuous care from early diagnosis through treatment and propose system changes to make screening more efficient. The project is supported by European and Czech funding and registered by national authorities.

Researchers are investigating invasive pulmonary aspergillosis (IPA), a serious lung infection mainly caused by Aspergillus fumigatus, which has increased in critically ill patients due to severe respiratory infections like H1N1 and COVID-19. Current diagnostic tools only provide probable IPA diagnoses, so this study aims to evaluate new biomarkers combining microbial siderophores and acute-phase proteins to confirm IPA more reliably and quickly. The goal is to enhance early diagnosis, improve treatment decisions, and potentially increase survival rates for critically ill patients. The study is prospective and will take place in intensive care units across five hospitals in the Czech Republic, involving critically ill patients suspected of IPA. Samples such as bronchoalveolar lavage fluid and endotracheal aspirate will be collected twice weekly from diagnosis until two consecutive negative results or ICU discharge. The new biomarkers will be analyzed using advanced mass spectrometry techniques, including MALDI-TOF, alongside established tests like Aspergillus qPCR and pentraxin 3 measurements. The study plans to enroll up to 90 subjects over three years, aiming to refine diagnostic thresholds and algorithms. Participants will undergo regular clinical and laboratory assessments, including imaging and mycological cultures, with data recorded in an online platform. Researchers will analyze biomarker levels, clinical symptoms, and treatment timing to classify IPA cases as possible, probable, or proven. The main outcome measure is the concentration of invasive pulmonary aspergillosis biomarkers detected by mass spectrometry over 31 months. The study includes careful safety and statistical evaluations to ensure reliable results and improve IPA diagnosis in critical care settings.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are conducting an observational, non-interventional, multicenter study to prospectively collect, store, and analyze biological samples from patients with conditions including Multiple Myeloma, Smoldering Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Myeloma, and MGUS. The study aims to establish a common international infrastructure for gathering standard clinical information at the start and during treatment while uniformly collecting and storing biological samples. The main intervention involves the collection and storage of biological samples from participants. The study does not involve treatment but focuses on creating a biobank that can be used for long-term research purposes, with sample storage planned for up to 30 years. Participants will provide written informed consent and contribute biological samples and clinical data. Researchers will monitor compliance with study requirements and follow-up schedules. The primary outcome is the establishment and maintenance of a biobank over a long-term period, supporting future research and analysis.