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Found 5 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
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.
Actively Recruiting
This research evaluates the long-term safety and effects of plozasiran in adults with hypertriglyceridemia HTG and severe hypertriglyceridemia SHTG. Participants must have completed prior related studies and meet specific health criteria, including controlled blood sugar levels HbA1c 10%. The study is designed as an open-label Phase 3 trial to extend understanding of this treatment in these populations. Participants will receive plozasiran injections under the skin approximately every three months for two years. They will continue following a low-fat diet according to local care standards. Some participants may join based on meeting additional criteria from previous studies, ensuring they fit the trials health requirements. During the study, participants will undergo regular assessments including monitoring for treatment-related side effects and changes in blood triglyceride and cholesterol levels. Researchers will track various blood markers and cardiovascular events over 24 months. Safety and response to treatment will be closely observed throughout the trial period.
Actively Recruiting
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.