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Found 4 Actively Recruiting clinical trials

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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.

Age: 18Years +All GendersPhase 3
588 locations
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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.

Age: 18Years +All GendersPhase 3
652 locations
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Actively Recruiting

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.

Age: 18Years +All GendersPhase 3
1149 locations
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Actively Recruiting

This observational registry study is focused on patients with hypertension who are candidates for renal denervation using the Paradise Ultrasound Renal Denervation System. The registry aims to collect real-world data on the long-term safety and performance of this catheter-based ultrasound treatment, which targets renal nerves to reduce blood pressure and prevent organ damage. The study is designed to monitor outcomes over an extended period in routine clinical practice settings. Participants include patients selected for treatment or those treated within six months before enrollment, based on their physicians assessment. The study collects data without altering standard care and records telemetric home blood pressure measurements and patient-reported quality of life outcomes. The Paradise System delivers ultrasound energy to ablate renal nerves while preserving the artery, aiming to reduce sympathetic nerve activity related to hypertension. Throughout the study, participants will have their health status tracked for up to five years after the procedure. Researchers will monitor various safety and efficacy measures, such as mortality, kidney function, cardiovascular events, and blood pressure changes using home, office, and ambulatory measurements. Quality of life will also be assessed regularly with standardized questionnaires. This long-term observation helps to understand the effects and safety of the Paradise System in everyday clinical use.

Age: 18Years +All Genders
55 locations