Subjects in this study will be over the age of 18 years and male or female (non-pregnant). Subjects must have advanced, chronic heart failure. Subjects will receive one dose of the Mydicar or placebo into the arteries of the heart and then be followed for up to 3 years to see the safety and effect on heart failure-related hospitalizations.
Research study looking for participants with type 2 diabetes and either cardiovascular disease or risk factors for cardiovascular disease (e.g. abnormal cholesterol, high blood pressure or tobacco use.) This study is being carried out to see if a new investigational drug called dapagliflozin when added to current treatment for diabetes is effective in reducing cardiovascular events such as heart attack, stroke, and death from heart disease, when compared with placebo (inactive pill having no effect). Medications, all study visits, blood work and study procedures are free of charge.
Capillary leakage leading to persistent pleural effusions and multiorgan dysfunction continue to be a significant post-operative problem in children following cardiopulmonary bypass (CPB). Studies to be performed as part of this research program will test the hypothesis that children with persistent pleural effusions have insufficiencies in an HDL-associated lipid, sphingosine-1-phosphate (S1P), that controls blood vessel barrier maintenance. If plasma levels of S1P are found to be predictive of persistent pleural effusions and prolonged post-operative recovery time after CPB then exogenous administration of S1P may hold promise in improving post-operative recovery after CPB.
A follow-up study (Fontan 2) at an average of 6 years after Fontan 1 has recently been completed. A limited re-evaluation of the original Fontan 1 cohort utilized the following outcomes: vital status, functional health status, interim medical events, access to health care and self-reported availability and willingness to participate in future studies. We are continuing to follow this unique group of individuals in order to assess how they are coping with this chronic disease process.
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).
This study is looking at Vitamin D and cardiovascular function in lupus patients who have low vitamin D levels. In this study, we expect to screen 50 or more participants for vitamin D deficiency by drawing blood by vein (up to 10 ml or two teaspoons). Of the first 32 screened who are vitamin D deficient, we will randomize (assign by chance) 16 patients to receive either a low, non replenishing dose (400 units (IU) daily) and 16 patients to receive a high, replenishing dose of vitamin D (5,000 IU daily) after measuring their blood vessel endothelial function by flow mediated dilation (FMD) and performing a history, physical examination, blood draw (up to 60 ml or 4 tablespoons), and urine collection. FMD is measured by putting an ultrasound probe (like a microphone with some jelly on top) on a blood vessel in the arm. Measures are taken before and after a blood pressure cuff is inflated on the arm to cut off blood supply for five minutes and then several minutes after release. After patients have taken vitamin D for 16 weeks, we will measure FMD again to determine if the endothelial function improves on the higher dose of vitamin D. We will perform a history and physical and draw blood (up to 60 ml or 4 tablespoons) and collect urine to determine mechanisms through which vitamin D might be improving vascular function.
The study involves subjects who have the Reveal implantable cardiac monitor. This monitor records information about the heart. Subject in this study will either have their heart information reviewed by the doctor and study staff to manage their heart failure or have their heart failure managed by standard ways (monitoring signs and symptoms of heart failure). The study will see if one way of managing heart failure versus the other has different outcomes for subjects.
This is a single-center, prospective, randomized, double blind, placebo controlled study of intraoperative MP in neonates undergoing CPB. Patients will be allocated to one of the 2 study groups in the ratio of 1:1. The randomization will be stratified by corrective vs. palliative surgery. The Primary Endpoint is a composite morbidity-mortality outcome, evaluated as intention to treat (ITT). Secondary endpoints include inotropic score, incidence of LCOS, fluid balance, ICU stay parameters, levels of inflammatory markers, safety parameters, and neurodevelopmental outcomes at 1 year. A two-sided test with a type I error rate of 0.05 will be used for all endpoints with no adjustments of the p-value for multiple testing.
This is a study comparing 2 different strategies for managing heart disease. One strategy called the invasive strategy will use early heart catheterization along with optimal medications to treat stable heart disease. The other strategy called conservative strategy will use optimal medications alone and use cardiac catheterization for patients once heart disease symptoms worsen.
This study is comparing the experimental drug azimilide to placebo in patients with implantable cardioverter defibrillators (ICDs) to determine if it can reduce emergency department visits and hospitalizations. Azimilide is an antiarrhythmic drug, which means it is used to treat abnormal heart rhythms.