Marianske Lazne 1

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating the impact of individualized sodium management during hemodialysis compared to standard treatment for patients with end stage renal disease on dialysis. The study aims to assess differences in fluid control, weight gain between dialysis sessions, blood pressure stability during treatment, and the rate of adverse events occurring during dialysis. Quality of life and overall wellbeing of patients will also be monitored to understand the effects of sodium control in this setting. Participants will be randomly assigned to one of two groups one receiving hemodialysis or hemodiafiltration with a sodium zero-diffusive treatment setting enabled on the dialysis machine, and the other receiving standard dialysis treatment without sodium control. Each patient will undergo thrice weekly dialysis sessions over a 12-week period, totaling 36 treatments. This approach allows comparison of the sodium management option available on 6008 HD dialysis machines versus the same machines operating without this feature. During the study, researchers will collect clinical data including measurements of fluid status, interdialytic weight gain, hemodynamic stability, and dialysis-related adverse events after 12 weeks of treatment. Patient-reported outcomes such as thirst, fatigue, hypotensive episodes, health-related quality of life, and general health status will also be assessed. Monitoring will ensure safety and collect detailed information about treatment effects over the 12-week trial period.

Researchers are studying the effects of a 21-day comprehensive spa care program on adults aged 40 to 70 years with chronic kidney and urinary tract conditions, including recurrent inflammation, nephrolithiasis, post-surgical recovery, and chronic prostatitis. The study aims to objectively measure changes in clinical and laboratory outcomes before and after treatment at a spa facility in Marinsk Lzn, Czech Republic. The treatment includes natural mineral spring water drinking three times daily, mineral water baths, mud therapy, carbon dioxide therapy, climate therapy, exercise therapy, and dietotherapy with nutritional counseling. Each participant receives 63 therapeutic procedures over 21 days, with some additional treatments prescribed individually by a spa physician. Assessments are done at the start and end of the treatment period. Participants undergo physical exams, ultrasound scans, blood and urine tests, body composition measurements, and psychometric questionnaire surveys at both time points. Data are pseudonymized and securely managed for analysis. The primary outcomes include changes in kidney function markers and urine cultures, while secondary outcomes assess quality of life, urinary symptoms, ultrasound findings, body composition, and vital signs. The total participation lasts for the 21-day spa treatment period.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.