Davenport

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the safety and effectiveness of the AcoArt Litos Paclitaxel Coated Balloon PCB catheter compared to a standard non-coated PTA balloon catheter in treating blockages in the infrapopliteal arteries of patients with chronic limb-threatening ischemia CLTI, specifically Rutherford category 4 or 5. The study aims to determine if the AcoArt Litos PCB offers better treatment outcomes while maintaining similar safety to the control device. This randomized controlled trial involves patients with critical blood flow issues in the lower leg arteries affecting limb health. Participants will be randomly assigned to receive either the PCB catheter experimental group or the standard PTA balloon catheter control group to treat narrowing or blockages in arteries below the knee but above the ankle joint. The devices are used during angioplasty procedures targeting vessels with specific size and lesion length criteria. The study includes a comprehensive evaluation of treatment success, safety events within 30 days, and longer-term vessel openness and limb outcomes over several years. During the trial, participants will undergo follow-up visits at multiple time points up to five years to assess limb health, vessel patency, wound healing, and adverse events. Researchers will measure outcomes such as major amputation-free survival, re-narrowing rates, and changes in blood flow indexes. Safety monitoring includes tracking major adverse limb events and peri-operative deaths shortly after treatment. Participants are expected to comply with scheduled visits and evaluations to provide detailed data on the treatments impact and durability.

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.

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.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

Researchers are studying the long-term safety and effectiveness of the Advance Evero18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter Evero drug-coated balloon for treating femoropopliteal artery lesions in patients with peripheral arterial disease PAD. The trial compares the Evero drug-coated balloon to commercially available paclitaxel-coated balloons to show that Evero is not less safe or effective. This is a randomized controlled trial designed to assess these outcomes in patients with PAD needing treatment in specific leg arteries. Participants will receive treatment with either the Evero drug-coated balloon delivering everolimus or a commercially available balloon coated with paclitaxel. Both treatments involve percutaneous transluminal angioplasty PTA targeting de novo or restenotic lesions in the native superficial femoral and popliteal arteries. The study is double-blinded and participants are randomly assigned to one of these two treatment groups. During the study, participants will be followed for safety and effectiveness outcomes, including death at 30 days and amputation or clinically driven target lesion revascularization within 12 months. The primary effectiveness endpoint is also measured at 12 months. The trial will monitor participants closely to collect these outcome data and ensure adherence to follow-up schedules. The study is expected to run until October 2032, with primary completion in September 2028.

This research aims to evaluate the safety and effectiveness of the FastWire System in patients with chronic total occlusions CTOs in the peripheral arteries causing ischemic limbs. It is a single-arm, multi-center, pivotal study involving up to 65 participants who meet specific inclusion and exclusion criteria. The study focuses on assessing whether the FastWire System can assist in placing guidewires or treatment devices beyond these arterial blockages. Participants will undergo a procedure using the FastWire System device to cross CTO caps and multiple lesions in their peripheral arteries. The study does not involve comparison groups and monitors clinical and technical success on the day of the procedure, along with safety events up to 30 days afterward. The device is used intra-luminally during the procedure to facilitate revascularization of lower limbs. During the study, participants will be closely monitored for clinical success and freedom from serious adverse events on the procedure day and up to 30 days post-procedure. Researchers will evaluate technical and procedural success, vessel dissection or bleeding within 24 to 36 hours, and any procedure-related mortality up to 30 days. The total study involvement lasts through the initial procedure and a 30-day follow-up period to assess safety and efficacy outcomes.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are conducting an observational study called XLPAD to evaluate the effectiveness and use of stent and non-stent therapies among patients with peripheral arterial disease PAD. This study aims to create a registry including data from procedures and clinical follow-ups, collecting information from patients treated since January 1, 2005, until 14,000 patients are enrolled. The study focuses on comparing outcomes like need for revascularization, surgical interventions, amputations, and safety events such as death, heart attack, stroke, and procedural complications over 12 months. Patients who receive endovascular interventions involving stents or percutaneous transluminal angioplasty PTA in specific leg arteries, including superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries, will be included. The study collects detailed background, lesion, intervention, and outcome data into an online system called REDCAP. Follow-up data is gathered at 6 and 12 months after the procedure, but follow-up visits are based on usual clinical care and not mandated by the registry. Treatment decisions, including use of stents or other therapies, remain at the discretion of the care team. Participants contribute by allowing the collection of their medical records, procedural details, and follow-up information. Data collected include patient characteristics, lesion features, treatment details, and clinical outcomes like walking distance and ankle-brachial index changes. Researchers will review events and outcomes up to 12 months post-procedure to assess treatment effectiveness and safety. The registry poses minimal risk since it observes routine care without altering treatments. Total participation duration depends on clinical follow-up timing, typically up to one year after the initial intervention.