Saint Jean Sur Richelieu

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 research aims to compare two pacing methods, His or Left bundle branch pacing HisLBBP and biventricular pacing BiVP, in patients with heart failure caused by left ventricular systolic dysfunction LVEF 50% who have either a wide QRS duration 130 ms or requireanticipate more than 40% pacing. The study focuses on patient-centered outcomes such as quality of life, physical activity, hospitalizations for heart failure, mortality, and device-related complications like lead dislodgement and infection, while participants continue standard heart failure medication. Participants are randomly assigned to receive either HisLBBP or BiVP devices. For patients with LVEF 35%, the HisLBBP group receives a defibrillator with three implanted leads, including a His-bundle or left bundle branch pacing lead, while those with LVEF 36-50% receive a pacemaker with two leads. The BiVP group receives a defibrillator with three leads for LVEF 35% and a pacemaker with three leads, including an epicardial left ventricular lead, for LVEF 36-50%. The pacing devices aim to synchronize heartbeats through different approaches to improve heart function. Throughout the study, participants are monitored for up to 5.5 years. Researchers will assess combined outcomes of all-cause death and heart failure hospitalizations as the primary measure. Secondary assessments include quality of life changes, psychological adjustment at one year, and heart function measured by left ventricular volume changes. Patient activity and heart failure symptoms will also be tracked using questionnaires, walk tests, and implanted device data. Safety and complications related to the devices will be closely followed during the study period.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.