Rheumatic Heart Disease

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index (MDPI) to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass (CPB). This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts: first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions; second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables; and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

Researchers are collecting clinical data on adults with symptomatic mitral valve disease, including those with mitral regurgitation, mitral stenosis, or mixed mitral valve disease. This observational registry aims to better understand the effects of correcting mitral valve disease on health outcomes, especially for patients who might be candidates for Transcatheter Mitral Valve Replacement (TMVR). The gathered information may also help guide future regulatory decisions for the Cephea Mitral Valve System. Participants include symptomatic patients considered suitable for TMVR by their heart care team, favoring this approach over conventional surgery or other therapies. The study will follow patients from enrollment for up to two years to observe their clinical progress. There are no specific treatments or interventions assigned by the study since it is observational. During the study, participants' health data will be collected regularly to monitor their condition and outcomes related to mitral valve disease correction. Follow-up includes reviewing clinical status and treatment effects over the two-year period. Participants must consent to data collection and follow-up visits, allowing researchers to evaluate the impact of TMVR candidacy on their health over time.

This research aims to evaluate the feasibility, sustainability, and public health impact of a district-based program for secondary prevention of Rheumatic Heart Disease (RHD) in Uganda. It is a non-randomized study testing the implementation of decentralized RHD preventive services, overseen by the Uganda Ministry of Health and District Health Offices in partnership with a technical quality assurance team. The study uses the RE-AIM framework to measure program reach, effectiveness, adoption, implementation, and maintenance while also estimating cost-effectiveness and budget impact. The study involves the ADUNU program, which integrates echocardiographic screening for RHD in children and young adults through community and facility-based testing. The program also includes registry-based secondary prophylaxis injections of Benzathine penicillin G (BPG) administered at local health centers (HCIII and HCIV) in the participating districts. This approach is designed to improve access to care and maintain patients linked to treatment. Participants and healthcare providers residing or working in the involved districts will engage with the program over several years. Researchers will assess the proportion of persons reached, enrolled, retained, and adherent to treatment at multiple time points up to five years. They will also evaluate program adoption and implementation at organizational, provider, and patient levels through surveys and interviews, alongside a cost analysis of the program at three years. The study ensures ongoing monitoring of adherence and outcomes to understand the program's public health impact.

Heart valve diseases are a leading cause of illness and death after coronary artery disease, hypertension, and heart failure. Mitral stenosis narrows the heart's mitral valve, limiting blood flow and causing symptoms like shortness of breath, fatigue, and difficulty with physical activity. This condition also reduces exercise capacity, worsens quality of life, and impairs respiratory function. Research groups studying these effects often lack uniformity, and most focus on patients who have undergone a specific procedure called percutaneous mitral balloon valvuloplasty. The study compares patients who have had surgery for mitral stenosis to healthy individuals. It evaluates exercise capacity using a cardiopulmonary exercise test, muscle oxygenation with near-infrared spectroscopy, respiratory functions with spirometry, respiratory muscle strength and endurance with specialized devices, aortic stiffness with an arteriograph, physical activity with a multisensor monitor, and quality of life using the SF-36 questionnaire. Participants include a patient group and a healthy control group, with assessments done over about one year. Participants will undergo various tests to measure exercise capacity, muscle oxygenation, aortic stiffness, respiratory muscle strength and endurance, lung function, physical activity, and quality of life. These tests include exercise testing, respiratory measurements, and monitoring of daily activity levels. The study tracks these outcomes continuously through one year to understand differences between those who had mitral valve surgery and healthy people. This helps researchers learn how surgery affects heart and lung function as well as overall well-being.

Researchers are investigating genetic factors that may contribute to human disorders of inflammation, including conditions like VEXAS syndrome and other autoinflammatory diseases. This exploratory natural history study aims to better understand these diseases by identifying genetic causes, examining immune system features, and describing clinical characteristics through medical record review. Participants include those with known or suspected autoinflammatory diseases, their family members, and healthy volunteers. Samples such as blood, saliva, hair, nails, or cheek swabs may be collected for genetic and immunologic studies. Some participants might also undergo skin biopsies. The study is observational and involves no treatment interventions. During the study, researchers will collect biological samples and review medical histories to discover genetic variants linked to inflammatory diseases. The main outcomes measured are the numbers of newly identified genetic changes that may cause or increase susceptibility to these disorders. Participation involves providing samples, consenting to medical record review, and may include follow-up over several years to monitor findings.

Researchers are evaluating the preliminary safety and effectiveness of the Cephea Mitral Valve System in treating symptomatic patients with mitral valve disease, including mitral regurgitation, mitral stenosis, and mixed mitral valve disease. The study focuses on patients for whom transcatheter therapy is considered more suitable than open heart surgery. This feasibility study is sponsored by Abbott Medical Devices and involves adult participants aged 18 years and older. Participants will receive treatment using the Cephea Mitral Valve System, a device designed to address mitral valve issues via a minimally invasive transcatheter approach. The study does not involve a control group or placebo and is not blinded. The primary outcomes measured 30 days after implant include freedom from all-cause mortality and reduction of mitral regurgitation to Grade I or less. During the study, participants will be monitored for safety and treatment effectiveness. Evaluations include assessments of mitral valve function and survival status at 30 days post-implant. Follow-up will help researchers understand the device's impact on mitral valve disease symptoms and patient outcomes. The total duration of participation may vary depending on individual follow-up schedules and assessments.

Researchers are exploring a new way to personalize treatment for autoimmune and autoinflammatory rheumatic diseases. This study aims to develop and use a special cell-based test that helps predict how well patients will respond to disease-modifying antirheumatic drugs (DMARDs). By identifying the best treatment for each person, the study hopes to improve treatment success, shorten the time to see benefits, and lower healthcare costs. The approach focuses on analyzing immune cells from patients to better understand their response to different therapies. The study includes several groups: newly diagnosed patients without prior treatment, patients already on immunomodulatory therapy, and healthy individuals for comparison. Blood samples are collected at different times depending on the group. Researchers use advanced laboratory methods to test immune cell responses to DMARDs outside the body, measuring specific immune signals and gene activity. Archived tissue samples are also studied to link immune profiles with disease features. This design allows detailed analysis of immune function related to treatment. Participants will provide blood samples and undergo clinical assessments over time, including baseline and follow-up visits at 6 and 12 weeks, with additional optional visits if disease worsens or treatment changes. The study measures changes in immune cell types and activity using the ex vivo assay and other tests. Data are stored securely, and the study will compare predicted responses with actual clinical outcomes to validate the test's usefulness. Participants' involvement may last up to a year, with ongoing monitoring and data collection to support personalized therapy development.

Researchers are evaluating the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System for treating tricuspid regurgitation, a heart valve disorder. The study aims to gather data to support the device's approval under Conformité Européenne (CE) marking. This clinical investigation is led by VDyne, Inc. and focuses on adults with severe tricuspid valve problems who are candidates for this treatment. Participants will receive treatment using the VDyne System, a device designed to replace the tricuspid valve via a minimally invasive procedure. The study includes one treatment group using this system. Key assessments will occur from baseline to one month after the procedure, with extended follow-up up to one year to track device-related major adverse events, valve function, quality of life, symptom status, and physical capacity. Throughout the study, participants will undergo imaging evaluations, functional tests like the 6-minute walk test, and quality of life questionnaires. Researchers will monitor safety and effectiveness at multiple time points, including 30 days, 3 months, 6 months, and one year after the procedure. The total duration of participation varies, with ongoing assessments to ensure comprehensive data collection and patient monitoring.

Researchers are evaluating the safety and clinical effects of the VDyne Transcatheter Tricuspid Valve Replacement System for treating people with symptomatic severe tricuspid regurgitation, a heart valve disorder. This study aims to assess how well the device works and its safety profile in improving symptoms and heart function in affected patients. The study involves implanting the VDyne system, which includes a bioprosthetic tricuspid valve and delivery tools, via a transfemoral approach while the heart is beating. The valve can be repositioned or retrieved during the procedure if needed. There is one treatment group receiving this device, and the procedure is guided by imaging techniques without the use of cardiopulmonary bypass. Participants will be monitored from the time of implant through one year after the procedure. Researchers will assess major adverse events, changes in valve function, symptom status, exercise capacity, and quality of life at various timepoints up to one year. Safety and effectiveness will be evaluated through imaging, clinical assessments, and questionnaires. The study starts with screening, implantation, and includes follow-up visits for ongoing evaluation.

Researchers are investigating the progression of moderate or greater cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, CT, and MRI data. The study aims to better understand disease progression, outcomes, and the effects of device interventions, medications, and lifestyle changes. It addresses the current lack of consensus on managing moderate valvular heart disease and the need for improved early warning mechanisms. This observational cohort study involves patients diagnosed with heart valve disease at major medical centers in China. Participants will be followed annually with outpatient visits including electrocardiography, echocardiography, blood tests, and contrast-enhanced CT scans. The study collects standardized data to identify factors that influence disease progression and adverse outcomes, guiding future treatment research. Participants will be monitored over several years with yearly assessments to track mortality, heart valve surgery, stroke, rehospitalization, valve disease progression, cardiac function, quality of life, and new cardiovascular complications. The study uses comprehensive imaging and clinical data to provide a scientific basis for improving clinical decision-making and patient care in valvular heart disease.