Hammond

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 the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

The trial investigates the use of Amnio-Maxx as an additional treatment for patients with diabetic foot ulcers (DFUs) that have not responded to standard care alone. It focuses on patients with Wagner grade 1 and 2 chronic ulcers, mostly including individuals aged 65 years or older. The study aims to assess how well Amnio-Maxx helps heal these ulcers compared to standard care, measuring wound closure and reduction in ulcer size over 12 weeks. Participants will first undergo a 2-week run-in period before being randomly assigned to receive either Amnio-Maxx combined with standard care or standard care alone. The Amnio-Maxx patch is processed using special aseptic techniques and dehydrated with saline. Patients will be monitored weekly for 12 weeks, with additional visits if needed for dressing changes. The study collects data on wound healing progress, pain levels, and safety. Throughout the study, participants will attend weekly visits for assessments including wound size measurements, safety checks, and pain evaluations. Healing will be verified independently at 12 weeks. Participants must follow offloading protocols for the ulcer site and provide informed consent. The trial tracks healing outcomes and monitors for adverse events, aiming to understand the effectiveness and safety of Amnio-Maxx in managing diabetic foot ulcers.

The purpose of this prospective, non-randomized, single arm, event-based, multicenter trial is to assess: (1) the diagnostic accuracy of the device, (2) the compliance of the prescribing physician, (3) the experience of the implanting physician, (4) the experience of the emergency department physician and (5) the patient compliance for "Emergency" and "See Doctor" alerts. The adequacy of the training program for the prescribing physician, implanting physician, emergency department physician, and patients will be assessed. A minimum of 500 patients who have had prior ACS events and who remain at high risk for recurrent ACS events will be enrolled in the PAS, for the purpose of accruing 314 adjudicated True Positive (TP) or False Positive (FP) ACS events. These ACS events will contribute to the Positive Predictive Value (PPV) and false positive rate (FPR) endpoints of the study. The PAS will be completed once the 314 ACS events have been collected and adjudicated.

Researchers are evaluating the effects of dalcetrapib, a cholesterol ester transfer protein inhibitor, on cardiovascular risk in people who have recently been hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, placebo-controlled, randomized, double-blind study focuses on adults aged 45 years and older. Participants must be clinically stable and managed according to guidelines for low-density lipoprotein cholesterol (LDL-C). The study aims to measure the time to the first occurrence of any fatal or non-fatal myocardial infarction over an average follow-up of 30 months. Participants will be randomly assigned to receive either dalcetrapib 300 mg tablets or matching placebo tablets. The study includes a genetic screening phase to confirm the presence of the AA genotype using a specific genotype assay test. Screening and enrollment may start during hospitalization or after discharge, with randomization required within 12 weeks of the ACS event. Follow-up visits will be conducted virtually when possible every 3 months or as clinic visits until the study ends. If a participant stops the study medication early, assessments for study endpoints will continue every 3 months. Throughout the study, participants will undergo medical history reviews, genetic testing, and regular assessments to monitor cardiovascular events. Researchers will collect data on myocardial infarction occurrences as the primary outcome. Safety and adherence will be monitored through scheduled visits, and the study will continue until about 200 participants have experienced a primary event or until a planned interim analysis determines stopping. The total participation duration varies based on event occurrence but involves ongoing follow-up every 3 months after randomization.

Researchers are evaluating 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 trial involves patients with chronic diabetic foot ulcers and aims to assess wound healing within 12 weeks. The study is conducted across multiple medical centers and includes a crossover option for patients not healed after initial treatment with standard care alone. Participants are randomly assigned to either standard care, which includes wound cleansing, debridement, moisture-balancing dressings, and offloading, or to standard care plus weekly applications of NeoThelium FT, a dual-layer membrane derived from donated human placental tissue. Those in the standard care group who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT weekly for up to 12 visits while continuing scheduled follow-up. Before randomization, all participants undergo a two-week screening phase. During the study, researchers will monitor wound closure rates, time to closure, wound area reduction, and pain. Assessments include measuring wound healing progress and ensuring ulcers remain free of infection. The study supports data collection for insurance reimbursement decisions and includes safety monitoring throughout the treatment and follow-up periods.

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating chronic open wounds. This randomized controlled crossover trial takes place at multiple medical centers and is open label, meaning both researchers and participants know the treatment being given. The study aims to support insurance decisions by gathering data on wound healing and pain reduction, focusing on wounds that have not sufficiently healed within 14 days prior to screening. Participants will be randomly assigned to either receive standard care alone—which includes wound cleansing, sharp debridement, moisture-balancing dressings, and offloading therapy—or standard care plus weekly applications of NeoThelium FT, a dual-layer wound covering made from human placental tissue. After about 84 days, those in the standard care group whose wounds have not fully closed may switch to the NeoThelium FT treatment for up to 12 weekly applications, continuing follow-up as scheduled. Participants will undergo a two-week screening before randomization. Throughout the study, researchers will monitor wound closure rates over 12 weeks, wound size reduction, and pain levels. Assessments will include wound measurements and evaluations for infection or complications. Safety and adherence to treatment protocols will be closely observed during the study period.