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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.
Actively Recruiting
Researchers are evaluating a new approach to guide cardiac resynchronization therapy (CRT) implantation using a cloud-based roadmap that integrates 3D electrical activation sequences from ECG and coronary venous anatomy from cardiac CT scans. This prospective, multicenter controlled study aims to see if this patient-tailored method can improve CRT outcomes by targeting the left ventricular lead placement to the electrically late-activated region. The study hypothesis is that at least 75% of patients receiving this guided implantation will show a 15% or greater reduction in left ventricular end-systolic volume after six months. Participants will undergo routine clinical evaluations including medical history, physical exams, 12-lead ECG, echocardiography, and computed tomography angiography to visualize heart structures. These imaging data will be uploaded to a cloud-based web platform where specialized software processes the information to identify the optimal site for left ventricular lead placement. The CRT device implantation will then be performed following local protocols, with the lead positioned based on the software's guidance and verified by X-ray. During the study, researchers will collect participant demographics, cardiovascular history, and clinical assessments. The primary outcome measure is the reduction in left ventricular end-systolic volume at six months post-implantation. Safety and feasibility will be monitored throughout. Participants are expected to be followed for at least six months to evaluate these outcomes.
Actively Recruiting
Researchers are evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.
Actively Recruiting
Autism Spectrum Disorder (ASD) is a complex condition with challenges in social communication and behavior, often accompanied by other physical and mental health issues that affect individuals and families. Early signs of ASD can appear in the first year of life, including reduced social interaction and repetitive behaviors. Early intervention during this period of high brain plasticity has shown promise in improving development and reducing symptoms. This trial aims to test FIRRST, a parent-led telehealth intervention designed for infants showing early signs of ASD, compared to standard parent education, to improve developmental outcomes and reduce caregiver stress. The study will enroll 132 infants aged 9 to 14 months who show early ASD symptoms. Participants will be randomly assigned to receive either the FIRRST intervention, which is based on naturalistic developmental behavioral methods and involves frequent, individualized activities to increase parent responsiveness, or a control group receiving written educational materials and monthly counseling sessions. The intervention will be delivered remotely by licensed health professionals over 24 weeks, followed by another 24-week follow-up period. Participants and their families will be evaluated at three times: at the start, after 24 weeks of intervention, and after 24 weeks post-intervention. Assessments will include developmental skills, ASD symptom severity, caregiver well-being, and brain activity measured by EEG. The study aims to provide evidence on the effectiveness of early telehealth interventions for infants at risk of ASD, potentially improving access to early support and reducing long-term impacts on families and society.