Myszkow

Atrial Septal Defect (ASD) is a type of congenital heart defect that can potentially be treated without open-heart surgery. Traditionally, ASD closure has been done surgically, but percutaneous transcatheter occluder devices offer a less invasive alternative. This research evaluates the Lifetech Cera™ ASD Occluder, a device designed for non-surgical closure of ASD, aiming to collect real-world clinical data and confirm its long-term safety and performance while identifying any unknown side effects. The study is a multi-center, single-arm post-market clinical follow-up involving patients who have already received the Lifetech Cera™ ASD Occluder device between January 1, 2020, and December 31, 2023. About 139 participants will be enrolled and followed for a total of 24 months after implantation. This follow-up will provide important information on the procedural success and ongoing safety of the device. Participants will be monitored through scheduled follow-up visits to assess the device's performance and any complications. Researchers will collect clinical data, including procedural success measured at 6 months post-implantation. The total study duration includes an enrollment period of approximately one year and a two-year follow-up post-implantation, ensuring long-term safety monitoring and data collection.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.