Clinical Trials
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
A Randomized, controlled efficacy study is to assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE. To evaluate apixaban pharmacokinetics and anti-Xa activity in pediatric subjects requiring anticoagulation for the treatment of a VTE.
PI: Sanjay Ahuja, MD, James Strainic, MD
Effect of Fetal Aortic Valvuloplasty on Outcomes
Multicenter study of outcomes after fetal cardiac intervention for critical aortic stenosis. Fetal aortic valve stenosis may progress to left heart hypoplasia with univentricular circulation after birth. Fetal aortic valvuloplasty has been proposed, but not proven, as effective in maintaining biventricular circulation after birth. This study is to determine if fetal aortic valvuloplasty improves left heart growth and/or function in utero and can increase the chance of biventricular repair. To evaluate if fetal valvuloplasty in aortic stenosis improves outcomes up to 2 years after birth compared with no fetal valvuloplasty.
Site PI: James Strainic
Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)
Multi-site NIH study to evaluate new management strategies and treatment for pregnant women with anti-Ro antibodies. This study follows subjects for 2 years to assess whether or not high antibody titer confers higher risk for heart block and if ambulatory FHRM can detect early fetal heart block.
Local PI: James Strainic, M
TOMORROW Study: Macitentan versus Standard of Care in Delaying Disease Progression of Pulmonary Arterial Hypertension for Children
This is a multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension. We are currently recruiting patients between the ages of 2-17 who have had pulmonary arterial hypertension for less than or equal to 5 years (with some exclusions). Children that are involved in this trial are randomly assigned to get the study drug, Macitentan, or standard of care.
Site PI: Dr. Amy DiMarino (Pediatric Pulmonology)
Co-investigators: Dr. Diana Drogalis-Kim (Pediatric Cardiology), Dr. Martin Bocks (Pediatric Cardiology)