Soest

Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease CKD and proteinuria, a condition where the kidneys leak protein into the urine. This study aims to evaluate the long-term safety of finerenone when added to standard treatments called ACE inhibitors or angiotensin receptor blockers ARBs, which are commonly used to control blood pressure and protect kidney function. The research also seeks to understand how well finerenone can reduce protein levels in urine and support kidney health over time. Participants will receive finerenone in doses adjusted by age and body weight, taken orally for up to 18 months alongside their usual ACEI or ARB treatment. The study includes patients who previously took part in a related trial and will follow them for about 19 months, including a one-month follow-up after treatment ends. The research involves one group receiving finerenone openly without placebo or comparison groups. During the study, participants will attend at least 8 to 12 visits depending on their treatment start status. At these visits, doctors will measure vital signs like blood pressure, heart rate, weight, and height perform physical exams collect blood and urine samples to monitor kidney function and protein levels and conduct heart tests using electrocardiograms and echocardiography. Participants and their caregivers will also answer questions about medication use, side effects, and overall well-being. Safety will be closely monitored by tracking any medical problems that arise during the trial.

Researchers are investigating whether early atrial fibrillation ablation reduces cardiovascular events in patients with atrial fibrillation who have a high burden of other health problems, measured by a CHA2DS2-VASc score of 4 or more. This is an international, randomized, open trial designed to compare early ablation with usual care to see if it lowers risks of stroke, cardiovascular death, or heart failure events. The study also looks at safety, patient-reported outcomes, and cognitive function in this population. Participants are randomly assigned to one of two groups one group undergoes early atrial fibrillation ablation, specifically pulmonary vein isolation within two months of randomization, while the other group receives usual care following guideline-based treatments tailored to their individual medical needs. All treatments involved are approved therapies. The trial aims to enroll 2312 patients and will continue until a set number of cardiovascular events have occurred, with an estimated average follow-up of about four years. During the study, researchers will monitor cardiovascular complications including death, stroke, and hospitalizations related to heart failure. They will also track serious complications from atrial fibrillation therapy and assess quality of life, heart function, rhythm status, cognitive function, and hospital stays over the follow-up period. Patients will be regularly evaluated for both safety and effectiveness outcomes throughout the study duration.