Havirov 1

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are conducting a national, prospective, multicenter, non-interventional pilot project to screen for Hepatitis C virus HCV infection among people who inject drugs PWID in the Czech Republic. The main goal is to prepare, implement, and assess a method for early detection of Hepatitis C and to develop new procedures for integrating this screening into social health care systems. This project aims to help prevent further transmission of the virus by improving early diagnosis and care continuity.

Researchers are investigating invasive pulmonary aspergillosis IPA, a serious lung infection mostly caused by Aspergillus fumigatus, which has increased significantly in critically ill patients, especially those with severe respiratory infections like COVID-19 and H1N1. Current biomarkers only suggest probable IPA, so this study aims to evaluate new low molecular weight substances combined with acute-phase proteins to confirm IPA quickly and accurately. The goal is to improve early diagnosis and treatment outcomes in intensive care patients. This study collects multiple types of samples such as tissue, bronchoalveolar lavage fluid, endotracheal aspirate, breath condensate, serum, and urine from patients suspected of IPA. Using advanced mass spectrometry techniques including MALDI-TOF, researchers will detect specific microbial markers alongside host proteins to confirm infection. Samples will be taken twice weekly until negative results or discharge, and stored samples from before diagnosis may also be analyzed. The study compares groups of patients with suspected IPA and those with probable or proven IPA. Participants will undergo regular testing including imaging, mycological cultures, PCR tests, and biomarker analyses. Data on clinical history, treatment, and biological markers will be collected and analyzed statistically to evaluate the diagnostic accuracy of the new methods. Results will be reported to clinicians in variable timeframes. The primary outcome is the concentration of IPA markers detected by mass spectrometry over 31 months. The study runs until the end of 2026 and involves critically ill adult patients in intensive care units.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

The study focuses on patients with various conditions related to plasma cells, including Monoclonal Gammopathy of Undetermined Significance MGUS, smoldering Multiple Myeloma SMM, Multiple Myeloma MM, and Plasma Cell Leukemia PCL. It is an observational, non-interventional, multicenter research project aimed at collecting, storing, and analyzing biological samples from these patients. The purpose is to create an international infrastructure for gathering consistent clinical data and biological samples at different stages of disease and treatment. Participants provide biological samples such as bone marrow aspirate, bone marrow biopsy, extramedullary disease EMD biopsy, peripheral blood, and serum at multiple timepoints. These include baseline, pre-maintenance or after one year of therapy depending on transplant eligibility, during maintenance therapy if part of standard care, and at first or later progression of disease. The study collects and stores these samples over a long period to support future research. Participants will undergo sample collections at scheduled times during their disease course and treatment phases. Researchers will monitor and analyze the stored biological samples and clinical data to support a biobank lasting up to 30 years. The study does not involve any experimental treatments but focuses on gathering data and samples to better understand the conditions. Participation requires written informed consent and compliance with the protocols follow-up schedule.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.