Kota Samarahan

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are comparing two heart procedures — a modern, imaging- and physiology-guided percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) — in people with type 2 diabetes who have significant disease in three heart arteries but not the left main artery. This study focuses on patients with diabetes and three-vessel coronary artery disease to determine which treatment approach results in better outcomes over two years. One group receives PCI guided by advanced imaging techniques like intravascular ultrasound or optical coherence tomography and physiological measurements such as fractional flow reserve or instantaneous wave-free ratio. They are treated with modern drug-eluting stents and receive optimal medical therapy including high-dose statins, advanced antiplatelet regimens, and anti-diabetic medications like SGLT-2 inhibitors or GLP-1 agonists. The other group undergoes standard coronary artery bypass surgery (CABG). Both treatments aim to restore blood flow in the affected arteries. Participants are followed for two years to monitor major adverse cardiac or cerebrovascular events. The study includes clinical follow-ups and assessments to evaluate the safety and effectiveness of the procedures combined with medical therapy. Patients must consent to the study protocol and follow-up schedule. This research helps understand the best revascularization strategy for diabetic patients with complex coronary artery disease.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating a personalized cardiac pacing treatment for people with heart failure who have a preserved ejection fraction (HFpEF), meaning their heart pumps normally but symptoms remain. This global, multi-center, randomized, controlled, and double-blinded study compares dual chamber personalized pacing to minimal or no pacing to assess safety and effectiveness. The study aims to improve heart failure symptoms and overall health status in patients with an ejection fraction of 50% or more. Participants will have a pacemaker implanted and then be randomly assigned to one of two groups. The treatment group will receive a personalized pacing rate based on individual height and heart function, while the control group will have the pacemaker set to minimize interference with their natural heart rate. Visits will occur at 2, 6, and 12 months post-implant, after which the control group will switch to personalized pacing. Additional follow-ups at 14, 18, and 24 months will collect more data, with yearly visits continuing until study completion. The total study duration is about 4.5 years, including enrollment and follow-up periods. During the study, researchers will collect data on heart function, exercise capacity, quality of life, and certain heart-related blood markers over a 12-month period. Safety will be monitored for major complications related to the pacemaker or procedure. Participants will attend scheduled visits for assessments including heart rate monitoring and questionnaires on symptoms and daily function. Long-term follow-up will continue beyond two years to evaluate lasting effects and safety of the personalized pacing approach.

Researchers are evaluating the feasibility and preliminary impacts of iSupport-Malaysia, an online program designed to support informal caregivers of people living with dementia in Malaysia. This pilot randomized controlled trial aims to compare the web-based iSupport-Malaysia intervention with its eBook version, focusing on caregiver psychological well-being, including burden, depression, anxiety, stress, and quality of life. The study also explores user perceptions regarding the usability and usefulness of the program. Participants will be randomly assigned to either the iSupport-Malaysia website or the eBook, both culturally adapted and delivered in the Malay language. The web version includes 23 lessons across 5 modules with videos, quizzes, and reflection exercises, while the eBook contains the same content in text-based format with quizzes and worksheets. Participants are encouraged to complete at least 10 lessons over a 3-month period, with reminders sent every two weeks. After the intervention, both groups gain access to both formats, and selected web group participants will take part in interviews about their experience. During the study, assessments on psychological well-being will be conducted online at baseline, 1 month, and 3 months. Researchers will monitor recruitment, randomization, retention, and program engagement rates. Participants' adherence is tracked via self-reports on usage frequency, lesson completion, and time spent. The study lasts 3 months per participant, with data collected through secure online platforms and follow-up interviews to understand user satisfaction and program impact.

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 the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.