Kota Samarahan

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are comparing two treatment approaches for patients with diabetes and significant three-vessel coronary artery disease CAD that does not involve the left main artery. This randomized study aims to evaluate outcomes between imaging- and physiology-guided state-of-the-art percutaneous coronary intervention PCI and coronary artery bypass grafting CABG. The trial focuses on how these methods affect major cardiac and cerebrovascular events in this patient group. Participants will receive either PCI guided by advanced imaging and physiological assessments, including intravascular ultrasound IVUS or optical coherence tomography OCT, and tools like fractional flow reserve FFR or instantaneous wave-free ratio iFR, along with modern drug-eluting stents and optimal medical therapy, or they will undergo standard CABG surgery. Both treatments are delivered under careful clinical protocols, and patients will be followed up extensively to assess various health outcomes. During the study, participants will be monitored for major adverse events over two years and other cardiovascular outcomes over five years. Assessments include hospitalization duration, rehospitalization rates, changes in functional class, quality of life questionnaires, medication use, and healthcare costs. The study aims to provide comprehensive data on the effectiveness and safety of these two revascularization strategies, with participants involved in clinical follow-ups and evaluations throughout the study period.

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.

Researchers are evaluating a personalized cardiac pacing therapy for patients with heart failure with preserved ejection fraction HFpEF who have a left ventricular ejection fraction of 50% or higher. This pivotal, global, double-blinded study compares the safety and effectiveness of dual chamber personalized pacing against minimal or no pacing. The goal is to improve health status and heart failure symptoms in these patients. Participants will receive an implanted Medtronic dual chamber pacemaker, either Astra XT or Azure XT models. After implantation, they will be randomly assigned to one of two groups. The treatment group will have their pacemaker programmed to a personalized pacing rate based on their height and baseline heart function, while the control group will have pacing set to minimize interference with their natural heart rate. At 12 months, the control group will switch to the personalized pacing rate. Follow-up visits will occur at 2, 6, 12, 14, 18, and 24 months, with annual visits thereafter until study completion. During the study, participants will complete scheduled visits including assessments of heart failure symptoms, six-minute walk tests, and biomarker measurements like NT-proBNP. Researchers will monitor cardiovascular events, pacemaker-related complications, and physical activity via device data. The primary outcomes focus on a composite of cardiovascular events and changes in patient health status over 12 months. The entire study is expected to last about 4.5 years, with up to two years of enrollment and 18 months of follow-up for each participant.

Researchers are evaluating the feasibility and preliminary effects of the iSupport-Malaysia program, an online psychoeducational intervention designed for informal caregivers of people living with dementia PLWD in Malaysia. This pilot randomized controlled trial aims to compare the web-based iSupport-Malaysia program with a culturally adapted eBook version. The study focuses on reducing caregiver burden and improving psychological well-being, such as depression, anxiety, stress, and quality of life, among caregivers. Participants will be randomly assigned to either the iSupport-Malaysia web-based intervention or the eBook group. The web intervention includes 23 lessons delivered through videos, quizzes, and reflection exercises on a learning platform, while the eBook group receives a PDF manual with similar content in text and quiz formats. Both groups are expected to complete at least 10 lessons over three months. After the intervention, participants in both groups will have access to both formats, and web group participants may join virtual interviews to share their experiences. Caregivers will complete online assessments at the start, one month, and three months after beginning the program, covering measures of psychological distress and quality of life. The study also tracks feasibility outcomes such as recruitment, retention, randomization, and program engagement. Reminder messages will encourage regular use. The total participation lasts three months, with data collected securely online and interviews conducted via videoconference for feedback.

This research aims to evaluate the effects of combining baxdrostat 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 a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

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.