Dendermonde

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 collecting and evaluating clinical data on various Abbott vascular medical devices used for conditions such as acute myocardial infarction, coronary artery lesions, restenoses, venous embolism, and arterial embolism. This prospective, non-randomized, open-label, multi-center registry aims to confirm the safety and performance of these devices over their expected lifetime. The study also focuses on monitoring identified risks, detecting new risks based on actual evidence, ensuring the benefit-risk balance remains acceptable, and identifying any misuse or off-label use of the devices. Participants are grouped based on the type of device used in their vascular procedure. These devices include coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging tools FFR and OCT, peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closurecompression devices, and vascular access introducers. Each participant receives the device relevant to their treatment as part of their procedure. During the study, researchers track participants from the start of their procedure, defined as the time a guidewire first enters the vasculature, until vessel closure following the procedure. They monitor outcomes such as death, myocardial infarction, target lesion revascularization, device-related complications, and procedural success at various points including during the procedure, at 30 days, and at 12 months. Participants are expected to follow a specified follow-up schedule to provide data on device safety and performance throughout the study duration, which runs until November 2031.

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 international, observational multi-centre study focuses on evaluating the safety, performance, and clinical benefit of the BeFlow Iliac Covered Stent System in patients with iliac artery stenosis or occlusion. The study aims to monitor the technical success of stent implantation, track clinical outcomes, and identify any potential unknown side effects related to the devices intended use. Participants will undergo endovascular treatment involving the permanent intraluminal placement of a covered stent in the iliac arteries to restore and improve blood flow. The study observes the devices performance over time without assigning experimental treatments, as it is an observational study involving real-world use of the stent. Throughout the study, participants will be monitored for various outcomes including the primary patency rate at 12 months, rates of stent-related complications, technical success, and changes in clinical classifications up to 60 months. Researchers will collect data on safety and effectiveness while following up for long-term results, with the study expected to conclude by the end of 2031.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating a new medicine called NNC6019-0001 for people with transthyretin amyloid cardiomyopathy ATTR-CM, a condition that affects the heart and leads to heart failure. This Phase 3 study compares NNC6019-0001 with a placebo to see if it can reduce the risk of heart-related death and illness. Participants will continue their usual heart treatments throughout the study. Participants will receive either NNC6019-0001 or a matching placebo through intravenous IV infusion. Both groups may also continue their standard heart failure treatments as advised by their doctors. The study is randomized and blinded so that neither participants nor researchers know who receives the medicine or placebo. Treatment and follow-up will last up to about 4 years. During the study, participants will have regular assessments including heart function tests, questionnaires about heart failure symptoms and quality of life, and walking tests to measure physical ability. Researchers will monitor heart-related events such as hospitalizations and urgent visits for heart failure, as well as death from cardiovascular causes. Safety labs and biomarker tests will be done. The main outcome is a combination of cardiovascular deaths and recurrent heart problems measured from the start to the end of the study.

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.

This research aims to improve prediction of surgery success for patients with borderline resectable BR and locally advanced pancreatic ductal adenocarcinoma LAPDA undergoing neoadjuvant chemotherapy with FOLFIRINOX. The study focuses on combining diffusion-weighted magnetic resonance imaging DW-MRI, radiomics, and multi-omics profiling of blood samples to better identify which tumors can be surgically removed. This approach seeks to reduce unnecessary surgeries and improve treatment decisions due to challenges in current imaging and tumor marker accuracy. Participants will receive standard care including CT scans, CA 19-9 blood tests, and FOLFIRINOX chemotherapy. Additional DW-MRI scans and blood samples for genetic and molecular analysis will be collected before and after chemotherapy. If imaging shows no tumor progression and CA 19-9 levels decrease, surgical exploration may be pursued. Blood samples will also be taken during surgery and at the first follow-up visit to further evaluate tumor characteristics and treatment response. Throughout the study, participants will undergo imaging tests, blood draws, and questionnaires about health status and quality of life. Researchers will analyze data to predict surgical resectability, assess complications, and evaluate disease-free and overall survival over several years. This comprehensive monitoring aims to enhance personalized treatment plans while minimizing risks from unnecessary procedures.

Researchers are evaluating a digital tool integrated into electronic health records to collect both clinical and patient-reported outcomes in men diagnosed with localized or locally advanced prostate cancer. The study aims to improve the quality of care by systematically capturing these outcomes over a long period. This observational study is led by Universitaire Ziekenhuizen KU Leuven and focuses on men aged 18 and older diagnosed with prostate cancer confined to or locally extending beyond the prostate gland without distant metastases. Participants will receive standard care for prostate cancer as determined by their treating physician. No additional medications or procedures are provided through the study. Clinical data will be recorded using predefined electronic forms within the health record system, while patient-reported outcomes will be collected electronically. Treatment decisions remain at the discretion of the physician, and no experimental interventions are involved. During the study, participants will be followed for up to 10 years after diagnosis. Researchers will assess the reporting of clinical parameters and patient-reported outcomes at various time points, including quality of life at diagnosis, 6 months, 1 year, and annually thereafter. They will also monitor disease recurrence, progression, overall survival, and prostate cancer-specific mortality. This long-term follow-up aims to support better understanding and management of prostate cancer outcomes.

Researchers are evaluating the safety and clinical performance of the Oscar Peripheral Multifunctional Catheter in patients with peripheral arterial disease affecting the femoral, popliteal, and infrapopliteal arteries. This prospective, multicenter, observational study aims to confirm procedural success and monitor in-hospital complications such as vessel perforation, rupture, acute occlusion, and distal embolization. The study includes patients with significant artery narrowing and specific lesion characteristics, who require endovascular intervention. The study uses the Oscar Peripheral Multifunctional Catheter, which includes three components the Oscar Support Catheter with integrated Lock Grip, the Oscar Dilator, and the Oscar PTA Balloon. The device is used to dilate lesions in the target arteries. The study focuses on procedural outcomes such as successful crossing of the target lesion, residual stenosis after vessel preparation, and absence of procedural complications. Treatments of inflow lesions may be performed before the target lesion treatment according to local standards. Participants will undergo the index procedure where procedural success and complications are closely monitored. Assessments include measuring procedural success rates, rates of adverse device effects, distal embolization, vessel rupture, perforation, and acute occlusion, as well as flow-limiting dissections and amputation occurrences within 30 days. Data on residual stenosis and crossing success will be collected. The study period extends until January 2026, with follow-up evaluations up to 30 days after discharge.