Bad Krozingen

Researchers are evaluating whether using an automated Carbon Dioxide CO2 injection system during infrainguinal peripheral vascular interventions PVI can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury CA-AKI. This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.

Researchers are conducting a prospective, multicenter, observational study in Germany to evaluate the clinical value and impact of serum neurofilament light sNfL as a prognostic marker for disease activity in patients with relapsing Multiple Sclerosis MS. The study focuses on patients who have received category 1 disease-modifying therapies DMTs and monitors routinely assessed sNfL values to better understand their role in patient management. Participants in the study either continue their current category 1 DMT treatment or switch to ofatumumab based on their physicians clinical judgment, independent of study enrollment. Category 1 DMTs include medications such as dimethylfumarate, diroximelfumarate, glatiramer acetate, interferon beta, and teriflunomide. Data will be collected over a maximum period of 24 months during routine clinical visits, with no specific protocol dictating observation frequency or diagnostic procedures. During the study, researchers will gather primary data including sNfL test results and track various outcomes like disease activity, treatment adherence, patient-reported fatigue, quality of life, and treatment satisfaction. Assessments will align with standard care practices and guidelines, and the study will measure outcomes at baseline, 12 months, and 24 months. The study aims to provide insights into the use of sNfL in clinical practice and its implications for managing relapsing MS.

Researchers are studying the safety and effects of a drug called DII235 in adults who have high levels of lipoproteina, a factor linked to heart disease and diabetes. This study is a Phase 2, randomized, double-blind trial aiming to find the best dose and to understand how DII235 affects lipoproteina levels over time compared to a placebo. Participants will be randomly assigned to one of five groups four groups receiving different doses of DII235 and one group receiving a placebo saline solution. The drug is given as an injection. The study will monitor participants from the start through Day 360, measuring changes in lipoproteina levels at several points, especially between Day 60 and Day 360. During the study, participants will have regular assessments including blood tests to measure lipoproteina levels, safety evaluations, and tolerability checks. Researchers will observe the percentage change in lipoproteina from baseline and the proportion of participants reaching certain target levels. The study duration per participant will cover at least 180 to 360 days, with careful monitoring for any side effects or safety concerns throughout.

This research aims to evaluate whether the medicine vicadrostat, combined with empagliflozin, helps adults who have chronic heart failure with a weakened heart pumping function, defined by a left ventricular ejection fraction under 40. Participants must have been diagnosed with chronic heart failure for at least three months and have symptoms classified as New York Heart Association class II to IV. The study is a Phase III trial conducted by Boehringer Ingelheim to assess the efficacy and safety of these medicines compared to placebo with empagliflozin. Participants are randomly assigned to one of two groups one group receives vicadrostat plus empagliflozin tablets, and the other group receives placebo tablets plus empagliflozin. Tablets are taken once daily for a period ranging from about six months up to approximately three and a half years. Participants continue their usual heart failure treatments during the study. The trial includes regular study visits and phone contacts to monitor health and treatment effects. During the study, participants will have their health regularly checked, including monitoring for worsening heart failure symptoms, hospitalizations, or death related to heart failure. They will also complete questionnaires about their well-being. The main measure is the time until the first cardiovascular death, hospitalization for heart failure, or urgent heart failure visit. Researchers will compare these outcomes between treatment groups to see if the combined treatment affects these events. Safety and any unwanted effects will be closely tracked throughout the study period, which can last up to about 3.5 years.

Researchers are evaluating the long-term safety and tolerability of pelacarsen TQJ230 in adults with established cardiovascular disease and elevated Lipoproteina who have completed a prior double-blind study. This open-label extension study follows participants from the parent trial CTQJ230A12301 to continue monitoring the effects of pelacarsen over an extended period. Participants will receive pelacarsen 80 mg once a month by subcutaneous injection during the open-label extension. This single-arm, multicenter study lasts up to 36 months, providing continued access to the study drug for those who completed the parent trial while still on the investigational product. During the study, participants will be regularly assessed for adverse events and cardiovascular outcomes, including major cardiovascular events tracked from both the parent study baseline and the extension study baseline. Lipoproteina levels will be measured at multiple time points to monitor changes over the course of the study. Safety and tolerability data will be collected up to 36 months, with ongoing monitoring by the research team throughout the study duration.

Researchers are evaluating the outcomes of different coronary artery bypass grafting techniques in women with heart disease. The trial compares multiple arterial grafting MAG to single arterial grafting SAG to see if using multiple arterial grafts improves major heart and brain-related events and quality of life. This international randomized clinical trial includes 2,300 women to assess differences in survival, stroke, heart attacks, repeat surgeries, and hospital readmissions, as well as physical and mental health. Participants will be randomly assigned to one of two groups. One group receives a single arterial graft using the left internal thoracic artery plus additional venous grafts. The other group receives multiple arterial grafts, including the left internal thoracic artery and at least one other arterial graft such as the right internal thoracic artery or radial artery, with possible additional arterial grafts. The study uses the infrastructure of an existing trial and follows patients for at least 2.5 years after surgery. During the study, researchers collect data on major adverse cardiac and cerebrovascular events, along with quality of life measured by general and disease-specific questionnaires. Physical and mental health symptoms are also assessed. Follow-up includes tracking deaths, strokes, heart attacks, repeat procedures, and hospital stays. The trial aims to provide detailed information on outcomes and quality of life in women undergoing coronary bypass surgery over a long-term period.

Researchers are evaluating whether performing percutaneous coronary intervention PCI on all significant blockages in patients with non-ST-segment elevation myocardial infarction NSTEMI and multivessel coronary artery disease is better than treating only the main culprit lesion. This open-label, randomized, controlled, multicenter trial aims to compare these two approaches to understand which provides better outcomes for patients with this heart condition. Participants will be randomly assigned to one of two groups. One group will receive optimal medical therapy and PCI only on the culprit lesion, with no further intervention on other blockages unless certain emergency criteria occur. The other group will receive complete revascularization of all significant non-culprit lesions, either during the initial procedure, hospitalization, or within 45 days after the initial PCI. During the study, participants will be followed for an average of two years to monitor outcomes including cardiovascular death, rehospitalization for heart attacks, and other heart-related events. Researchers will also assess quality of life and complications such as bleeding, stroke, and kidney injury at various time points. The study involves regular evaluations and aims to gather comprehensive data to determine the best treatment strategy for these patients.

Researchers are evaluating treatments for patients with high-risk pulmonary embolism, a serious condition where blood clots block blood flow in the lungs. The trial compares early catheter-directed treatment plus conventional care against conventional care alone. This open-label, multicenter, randomized controlled trial aims to assess which approach better reduces mortality and severe complications within seven days. Participants are randomly assigned to one of two groups. One group receives conventional care following guidelines, including reperfusion treatments, with catheter-based intervention only if no improvement occurs. The other group undergoes catheter-interventional treatment within 60 minutes of randomization, using certified devices such as aspiration thrombectomy and local fibrinolytic therapy, possibly combined with ultrasound assistance. Sheaths used during the catheter procedures are removed shortly after treatment, and fibrinolytic drugs are prepared concurrently to avoid delays if needed. Throughout the study, researchers monitor participants closely, measuring outcomes like death from any cause, recurrent cardiac arrest, and shock within seven days. Secondary outcomes include mortality at 30 days, bleeding events, use of life support devices, heart function changes via echocardiography, ICU stay length, and time to stabilize blood flow. The trial is led by Leipzig Heart Science gGmbH and participants are followed up to assess these key health indicators.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

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.