This is a clinical study looking at the effectiveness and safety of a new device called The Paradise System to use for renal denervation in patients who have mild to resistant hypertension. The goal of renal denervation is to lower blood pressure by using ultrasound waves to heat and disable the nerves surrounding the blood vessels leading to the kidneys. It is believed these nerves may be too active in patients with high blood pressure. The study is divided into two groups, those on one to two anti hypertensive medications (Solo) and those on three or more(Trio). The Trio group will stop their current medication regime and be given one of two combination medications while monitoring their blood pressure. If they continue to meet inclusion criteria, they will be randomized to undergo a renal denervation procedure using the new system versus no procedure. Their assignment will not be made known to them until their six month follow up visit. All groups will be followed up to 3 years but patients who did not initially have the procedure will have the opportunity to have it at a later date.
This research which encompasses a relatively new area of study that uses the Ecological Model to frame investigation is significant because it will help: (a) understand how patient, family, and community level factors impact stroke recovery and account for disparities in post stroke recovery between AA and Whites; (b) engage community members (AA, Health Provider, Families) and (c) integrate this knowledge and the interplay of socio-environmental and behavioral factors so as to develop a multi-level community based intervention with community dwelling AA in the acute post-stroke recovery period. In this model of care, the nurse guides the CHW in evidence-based interventions and the CHW links with community members to deliver the interventions to individuals. It uses nurse teleHealth guidance of the CHW and home based CHW-patient training in self-management. Together they work to disseminate and integrate the successful interventions into health and community systems. These activities will complement and build upon the growing literature related to environment guided lifestyle and self -management programs and will lead to effective socio-culturally tailored stroke recovery interventions that improve long term outcomes by directly addressing factors associated with existing disparities in recovery.
The purpose of this study is to show whether the Barostim Neo system is safe and works in people with heart failure. The device is designed to stimulate the body's natural cardiovascular regulators in your neck to potentially improve your heart failure condition.
This study is being done to see if receiving electrical treatment from a cardiac resynchronization therapy (CRT) device with the AdaptivCRT (aCRT) programming feature is better than receiving electrical treatment from a CRT device with the standard method of CRT device programming in patients with heart failure. Subjects will receive an already approved CRT pacemaker or defibrillator depending on what the doctor recommends. Approximately 3000 subjects will be enrolled at up to 200 centers around the world.
Heart disease can be detected in the hospital by Cardiac Magnetic Resonance (CMR)- a device that uses a large magnet. CMR is used to test how healthy the heart muscle is and how well the heart is pumping. We will test a new method to see how helpful it is to quickly get good pictures and if this is useful for testing the health of heart muscle in patients with heart disease.
Disease of the blood vessels in the legs can be detected in the hospital by Magnetic Resonance Angiography (MRA)- this uses a device that acts like a large magnet. MRA is used to test how healthy the blood vessels are and if there are any blockages. We will test a new method to see how helpful it is to quickly get good pictures and if this is useful for testing the patients with disease of the blood vessels in other regions of the body.
The majority of drugs administered to children are used off label and PK studies to define appropriate dosing are lacking across pediatric age groups. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard of care procedures have proven successful in characterizing the PK of drugs used in children.
The purpose of this study is to characterize the PK of understudied drugs administered to children per standard of care as prescribed by their treating caregiver.
This study will serve as a tool to better understand drug exposure in children receiving drugs per standard of care. The data collected through this initiative will provide valuable PK and dosing information drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Kidney failure occurring after heart failure is a serious problem leading to prolonged ICU stay, prolonged hospitalization, dialysis and death. The goal of this study is to identify patients who will develop severe kidney failure after heart surgery. Early identification of patients who will develop kidney failure after surgery will allow earlier and better treatment to prevent this complication. In this study, urine is collected after surgery and analyzed to determine the concentration of many proteins. These proteins are potential biomarkers to predict the development of kidney failure. This is a multi-center study funded by the National Institutes of Health. It is being performed at Duke University, George Washington University and the University of Tennessee. MUSC is the lead center.