Carnaxide

Researchers are evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and hard-to-treat autoimmune diseases. These diseases include systemic lupus erythematosus SLE with nephritis and rheumatoid arthritis RA. The trial aims to understand how these treatments work in different groups of participants with these conditions through multiple subprotocols. Participants will receive either inebilizumab through intravenous infusions or blinatumomab through subcutaneous injections. Different dosing schedules are used for each drug, including three or four doses for inebilizumab and various low, medium, or high doses for blinatumomab. The study is divided into subprotocols focusing on different patient groups and dosing parts. During the study, participants will be monitored for treatment-emergent adverse events and serious side effects over up to 52 weeks. Researchers will assess kidney response, disease remission, and disease activity scores at various time points. Blood tests, antibody measurements, and disease activity indices will be used to evaluate the participants responses and safety. The study lasts from the first day of treatment through week 52 with ongoing evaluations.

Researchers are evaluating DMX-200 repagermanium, a drug that blocks a receptor involved in inflammation, in patients with focal segmental glomerulosclerosis FSGS who are also receiving an angiotensin II receptor blocker ARB. This Phase 3 study aims to assess the safety and effectiveness of DMX-200 compared to placebo over two years in adults and adolescents aged 12 to 17 years. The study is led by Dimerix Bioscience Pty Ltd and includes a double-blind period followed by an open-label extension to observe long-term effects. Participants receive either 120 mg of DMX-200 or a matching placebo capsule twice daily for 104 weeks during the double-blind treatment phase. Afterward, those who complete this phase may enter a two-year open-label extension where all participants receive DMX-200 twice daily. The study includes a screening and qualification period lasting 6 to 14 weeks, a possible titration phase, a stabilization phase, and a follow-up period after treatments. Throughout the trial, patients will undergo assessments including urine proteincreatinine ratio and kidney function tests like estimated glomerular filtration rate eGFR at multiple time points up to week 104 and during the extension. Safety and tolerability are closely monitored through regular evaluations, adverse event tracking, and follow-up visits. Total participation may last about 230 weeks, covering all study phases and follow-up periods.

Researchers are studying the use of felzartamab for adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by buildup of abnormal IgA antibodies that damage kidney filters. The study aims to understand how felzartamab affects proteinuria, or protein in the urine, as well as kidney function, safety, and how the body processes the drug. This research is a Phase 3 randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney function will receive treatment in separate cohorts. After treatment, there is an 80-week follow-up period. In total, participants will have 17 study visits over about two years. During the study, researchers will measure changes in urine protein levels, kidney filtration rates, and other clinical endpoints. They will also monitor felzartamab levels in the blood, immune responses, and any adverse events. Safety assessments include vital signs, lab tests, ECGs, and physical exams. The study tracks participants closely throughout treatment and follow-up to evaluate felzartamabs effects on IgAN.

Researchers are evaluating finerenone, a medicine that blocks a protein involved in heart and blood vessel damage, to see if it helps children with heart failure and left ventricular systolic dysfunction LVSD. Heart failure in children means the heart cannot pump enough blood, causing symptoms like tiredness, shortness of breath, and poor growth. This is the first study exploring finerenone specifically for this condition in children aged 6 months to less than 18 years. Participants will be randomly assigned to receive either finerenone or a placebo, which looks like the medicine but has no active drug, for about 3 months alongside their usual heart failure treatments. After this period, those who qualify can join an additional 9-month open-label phase where all will receive finerenone. During the study, children will visit the clinic at least three times for treatment and monitoring. Throughout the study, doctors will check vital signs, perform heart exams using ECG and echocardiogram, take blood samples, and ask about medicines and any health problems. Researchers will measure changes in a blood protein called NT-proBNP that indicates heart stress and monitor safety by tracking any side effects. Participants who do not join the extension phase will have a follow-up visit 30 days after their last treatment.

Researchers are collecting clinical data to assess the ongoing safety and performance of commercial Biosense Webster Inc. BWI medical devices used during routine cardiac arrhythmia mapping and ablation procedures. The study focuses on patients with cardiac arrhythmias, including atrial fibrillation, supraventricular tachycardia, and ventricular tachycardia. This observational post-marketing study aims to confirm the safety and performance of these devices in real-world settings and expand knowledge about their use in treating arrhythmias. Participants diagnosed with cardiac arrhythmias and scheduled for an ablation procedure will be observed while treated with commercially approved BWI devices such as the BWI therapeutic catheter, Varipulse Catheter, or Dual Energy THERMOCOOL SMARTTOUCH SF Catheter. These devices are used according to routine clinical practice without a specific intervention dictated by the study. Sub-studies include participants treated with the Varipulse Catheter VARIPURE and the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter DUACURE. During the study, participants will be monitored for safety and effectiveness outcomes, including adverse events related to the device or procedure within 7 days and up to 365 days after treatment. Measurements include success rates in isolating targeted pulmonary veins, achieving non-inducibility of tachycardias, freedom from arrhythmia episodes, and rates of repeated ablation. Data collection aligns with standard hospital care and includes follow-up assessments over one year, providing comprehensive information on device performance and patient outcomes.

Researchers are evaluating a personalized prevention program PPP for people with stable coronary heart disease CHD who are at high risk of cardiovascular events. The study includes two parts Part A screens 12,000 stable CHD subjects using biomarkers to identify those at highest risk, while Part B is a randomized clinical trial comparing usual care to the PPP in 2,000 high-risk subjects. The goal is to assess the clinical value and cost-effectiveness of the PPP and validate risk biomarkers for predicting cardiovascular events. Participants in the PPP group will visit the study site six times over three years to receive lifestyle coaching, exercise prescriptions, and medication guidance following European Society of Cardiology guidelines. These activities are supported by digital tools called the CoroPrevention Tool Suite. The usual care group will continue receiving standard care from their physicians and have two study visits during the three years. Participants will undergo evaluations including biomarker measurements, behavioral assessments, questionnaires on nutrition and exercise, and monitoring of cardiovascular events. The study will track outcomes like cardiovascular death, heart attacks, and heart failure over three years. Researchers will also study the impact of behavioral changes, adherence to exercise and medication prescriptions, and the economic value of the prevention program. Safety and progress will be monitored throughout the study period.

Researchers are evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.

Researchers are evaluating maridebart cafraglutide in adults aged 45 to 99 years who have atherosclerotic cardiovascular disease and are overweight or obese. The study aims to determine if maridebart cafraglutide, when added to standard care, is better than a placebo in reducing serious heart-related problems and deaths. This is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Amgen. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is given alongside their usual care. The trial will last for approximately 35 months, during which time researchers will monitor cardiovascular events such as heart attacks, strokes, and deaths, as well as other health measures. During the study, participants will have regular visits for monitoring safety and health status. Researchers will assess heart-related events, blood pressure, body measurements, blood markers such as cholesterol and blood sugar levels, and kidney function. The main outcomes include time to first major cardiovascular event and changes in various health indicators over about three years. Safety monitoring will continue throughout the trial period.

Researchers are comparing the safety and effectiveness of the Myval Transcatheter Heart Valve THV Series with other contemporary valve devices, specifically the Sapien THV Series and Evolut THV Series, in patients with severe symptomatic native aortic valve stenosis. This prospective, randomized, multinational trial aims to determine if the Myval THV Series performs at least as well as these established valves for treating this condition. The study will enroll a total of 768 participants, with equal numbers receiving either the Myval THV or the contemporary valves. Participants will receive heart valve replacements via the transfemoral approach using valves sized appropriately for their anatomy. The Myval THV Series includes several device sizes ranging from 20 mm to 29 mm, while the comparator devices include Sapien and Evolut valves in various sizes. The trial also features a non-randomized nested registry to evaluate extra-large Myval valves 30.5 mm and 32 mm and a lead-in phase where investigators perform initial implantations to ensure protocol adherence before enrolling study subjects. Throughout the study, participants will be closely monitored with assessments of valve safety and effectiveness using criteria defined by the Valve Academic Research Consortium-3 VARC-3. Outcomes measured include mortality, stroke, kidney injury, bleeding, valve function, device success, and quality of life, among others, followed up to 10 years. The study includes detailed safety and efficacy evaluations at multiple time points, including pre-discharge, 30 days, 1 year, and longer-term follow-ups. Participants will undergo clinical evaluations, echocardiography, and quality of life questionnaires during these visits.

Researchers are evaluating the safety and effectiveness of the Vienna Aortic Valve SE System, a new self-expanding transcatheter heart valve, in patients with symptomatic severe aortic stenosis. This prospective, single-arm, multicenter trial includes up to 267 patients and follows them for up to five years after valve implantation. The study aims to gather important data beyond an initial feasibility study to better understand this devices performance over time. Participants will receive the Vienna Aortic Valve SE System through a transcatheter aortic valve implantation TAVI procedure. After implantation, patients will have 11 scheduled visits, including follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years. These visits allow researchers to monitor the devices safety and effectiveness throughout the study period. During the trial, participants will undergo clinical evaluations including assessments of mortality, valve function, and heart-related events. Quality of life and exercise capacity will also be measured. Monitoring includes checking for complications like bleeding or conduction problems requiring pacemakers. The study concludes after each participant completes their 5-year follow-up visit, providing long-term information on the valve systems outcomes.