Krapinske Toplice

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.

Researchers are studying the safety and effectiveness of NNC0487-0111 for adults with excess body weight and type 2 diabetes. This Phase 3 clinical trial compares NNC0487-0111 with a placebo to see how well the medicine helps reduce body weight when taken along with diet and exercise changes. Participants have type 2 diabetes for at least six months and meet specific health criteria to join the study. Participants are randomly assigned to receive one of four different doses of NNC0487-0111 or a placebo. Each treatment is given as a weekly injection under the skin using a pre-filled pen injector, targeting areas like the thigh, abdomen, or upper arm. All participants follow a reduced-calorie diet and increase physical activity during the study. The main treatment period lasts 84 weeks, with body weight and other health measures tracked throughout. During the study, participants will have regular assessments including blood tests to check blood sugar levels, cholesterol, and other health markers. Researchers will also monitor waist size, blood pressure, and quality of life related to physical function. Safety is carefully watched by tracking any side effects or adverse events until 88 weeks. Overall, participants are involved in frequent visits and health evaluations to measure treatment impact and safety over nearly two years.

Researchers are conducting the CARAMEL-OS observational study to develop and validate personalized artificial intelligence models for assessing cardiovascular risk in women aged 40 to 60 years during their menopausal transition. This project involves a collaboration of 25 organizations across Europe and Colombia, aiming to improve cardiovascular disease prevention by integrating multi-source data, including socioeconomic, clinical, biochemical, imaging, and novel non-invasive variables related to female-specific risk factors and menopause. The study will recruit a prospective cohort of 3,000 women from six clinical sites in four European countries and Colombia, with 500 participants contributed per site. Participants will be observed without any clinical intervention, using digital self-assessment and self-management tools, including a mobile app designed to support women during menopause. Data collected will help refine cardiovascular risk stratification models and develop new predictive tools with short-term horizons. Participants will be involved in assessments spanning 21 to 24 months depending on enrollment, during which incidence of hypertension, dyslipidaemia, diabetes mellitus, and cardiovascular disease will be recorded. Mortality related to cardiovascular events will also be tracked. The study focuses on gathering comprehensive data through questionnaires, imaging, biochemical tests, and digital monitoring to support personalized prevention strategies and advance precision medicine in womens cardiovascular health.

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.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.