Hammond

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 studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.

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.

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 study involves patients who have had previous acute coronary syndrome ACS events and are at high risk for recurrent ACS. It aims to evaluate the AngelMed Guardian System, an implantable cardiac monitor that alerts patients to potential ongoing ACS events. The study will assess the devices diagnostic accuracy, physician compliance, patient compliance with alerts, and the adequacy of training programs for physicians and patients. Participants will be implanted with the AngelMed Guardian System and receive standard care, including an initial programming visit 7 to 14 days after implantation and follow-up visits every 6 months. The study is event-based and will continue until 314 adjudicated true or false positive ACS events have been collected. The device detects sustained ST segment changes and alerts patients to seek medical attention for potential ACS events, including asymptomatic ones. During the study, patients will have regular in-office visits for device programming and monitoring. Researchers will track the occurrence of ACS events, patient and physician responses to alerts, and the effectiveness of training programs. The main outcome measures include the devices positive predictive value and false positive rate. The study will last for approximately 3 years, with follow-up visits every 6 months until study completion or exit.

Researchers are evaluating the effect of dalcetrapib on cardiovascular risk in people recently hospitalized for acute coronary syndrome ACS who have a specific genetic profile AA genotype. This phase 3, randomized, double-blind, placebo-controlled study focuses on adults aged 45 years and older, aiming to assess the time to first occurrence of fatal or non-fatal myocardial infarction over an average of 30 months from randomization. The study will continue until around 200 participants experience a primary event, or until stopped at an interim analysis. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily, two 300 mg tablets or matching placebo tablets once daily. Screening includes genetic testing for the AA genotype using a specialized Genotype Assay Test. Enrollment can begin during hospitalization or after discharge, but randomization must occur within 12 weeks of the ACS event. After randomization, follow-up visits will be virtual when possible or in clinic every three months until the study ends. Assessments will continue every three months for participants who stop the study medication early. Participants will undergo medical history review and genetic testing before enrollment. During the study, researchers will monitor cardiovascular events such as heart attacks and strokes through regular assessments every three months. Safety evaluations and collection of study endpoints will continue for the duration of participation, which may last approximately 30 months or until the study stops. This includes ongoing monitoring for adverse effects and overall health status.

The trial investigates the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating diabetic foot ulcers. This open-label randomized controlled crossover study is conducted across multiple medical centers and aims to evaluate wound healing outcomes and pain relief in patients with chronic diabetic foot ulcers. The study includes adult participants with diabetes mellitus who have ulcers that meet specific criteria. Participants are randomly assigned to receive either standard care alone or standard care plus NeoThelium FT, a wound covering made from human placental tissue. Those initially receiving standard care who do not achieve complete wound closure by about 84 days may cross over to the NeoThelium FT treatment arm, receiving weekly applications for up to 12 visits. All participants undergo a two-week screening before randomization. During the study, participants have regular assessments including wound measurements and pain evaluations at specific intervals over 12 weeks. Researchers monitor the percentage of ulcers achieving full closure, wound area reduction, time to closure, and pain levels. The trial supports gathering data for insurance reimbursement decisions and tracks participants through follow-up visits according to the study schedule.

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard wound care compared to standard care alone in treating chronic open wounds. This randomized controlled crossover trial involves patients with chronic open wounds that have not healed sufficiently, aiming to assess wound closure rates within 12 weeks. The study is open label and conducted at multiple medical centers, supporting post-marketing evaluation and insurance reimbursement decisions. Participants will be randomly assigned to receive either standard care alone or standard care plus weekly NeoThelium FT applications. Those initially receiving standard care who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT with standard care for up to 12 additional weekly treatments. Standard care includes wound cleansing, debridement, moisture-balancing dressings, and offloading. Before randomization, participants undergo a two-week screening phase. Throughout the study, wound healing progress and pain levels are regularly assessed, including wound area measurements and pain evaluations at specified time points. The primary measurement is the rate of complete wound closure within 12 weeks, with secondary outcomes assessing wound size reduction and pain. The study duration extends through treatment and follow-up visits, concluding by October 2026.

Researchers are evaluating maridebart cafraglutide as an additional treatment to standard care for adults with heart failure who have preserved or mildly reduced ejection fraction, and who are also obese. This phase 3, global, multicenter trial aims to see if this drug can reduce heart failure events like hospitalizations and urgent visits, lower cardiovascular deaths, and improve heart failure symptoms. The study has a double-blind phase and an open-label extension, and it will continue until about 850 primary endpoint events occur. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given by subcutaneous injection. The trial lasts up to approximately 35 months and includes assessments at various time points to measure heart failure events, cardiovascular deaths, kidney function, blood pressure, weight, blood sugar, cholesterol, and quality of life using questionnaires. The study also tracks serious adverse events and drug concentrations. During the trial, participants will have regular visits for monitoring, including questionnaires, laboratory tests, and physical assessments. Researchers will evaluate the time to first cardiovascular events and heart failure hospitalizations as the main outcome. Secondary measures include changes in symptoms, kidney health, blood pressure, and metabolic factors. Safety will be monitored throughout, with follow-up continuing up to about 35 months from the start of treatment.