Trials & Studies

Clinical Trials and Prospective Studies

At any given time, Boston Children’s Hospital has hundreds of clinical trials underway.  The following is a snapshot of current Heart Center trials: 

Adjunct Targeted Biologic Inhibition in Children with Multivessel Intraluminal Pulmonary Vein Stenosis (PVS)
This study aims to determine whether the biologic agents Avastin® and Gleevec® are effective in treating the progression of multivessel intraluminal pulmonary vein stenosis in children.
Contact: Michelle Cook (Michelle.Cook@cardio.chboston.org; 617-919-4129)

STORCC: STandardized Outcomes in Reproductive Cardiovascular Care
This study involves a standardized assessment for women with heart disease in pregnancy. The goals of this project are 1) to develop guidelines for screening women with cardiovascular disease who desire pregnancy; 2) to propose appropriate clinical management for women with heart disease throughout pregnancy and during the postpartum period; and 3) increase patient knowledge regarding their personal risks during pregnancy and the postpartum period. Women may be enrolled throughout their pregnancy.
Contact: Anne Marie Valente, MD (anne.valente@cardio.chboston.org; 617-355-6508, *4) or Emily Dollar (EDollar@partners.org)

Arterial Stiffness and Cardiac Risk in Youth
This study aims to understand how arterial stiffness—which in adults predicts heart disease, stroke and high blood pressure—starts in youth. Participants receive $50 cash plus free parking/MBTA/taxi voucher. Visits can be combined with clinic visits, where clinical labs can be drawn at the same time. Patients 13-21 may be eligible to participate.
Contact: Teena Smith (teena.smith@cardio.chboston.org; 617-355-0955)

Pulmonary Artery Repair with Covered Stents (PARCS)
This study will evaluate the safety and efficacy of a covered CP stent in repairing RV-PA conduit disruption during transcatheter pulmonary valve placement with Melody TPV.
Contact:  Lisa Bergesen, MD, MPH (lisa.bergesen@cardio.chboston.org; 617-355-6529)

Other Research highlights

Selected from among 89 publications by Heart Center faculty between May 1, 2014, and October 1, 2014.

DeWitt ES, Abrams DJ. Implantable cardioverter-defibrillators in children. Arch Dis Child. 2014.   

Goldberg CS, Lu M, Sleeper LA, Mahle WT, Gaynor JW, Williams IA, Mussatto KA, Ohye RG, Graham EM, Frank DU, Jacobs JP, Krawczeski C, Lambert L, Lewis A, Pemberton VL, Sananes R, Sood E, Wechsler SB, Bellinger DC, Newburger JW; Pediatric Heart Network Investigators. Factors associated with neurodevelopment for children with single ventricle lesions. J Pediatr. 2014;165(3):490-496.e8.   

Emani S, Trainor B, Zurakowski D, Baird CW, Fynn-Thompson FE, Pigula FA, Emani SM. Aspirin unresponsiveness predicts thrombosis in high-risk pediatric patients after cardiac surgery. J Thorac Cardiovasc Surg. 2014;148(3):810-6.   

Yuki K, DiNardo JA. Comparison of actual oxygen delivery kinetics to those predicted by mathematical modeling following stage 1 palliation just prior to superior cavopulmonary anastomosis. Paediatr Anaesth. 2014.   

Buber J, Assenza GE, Huang A, Valente AM, Emani SM, Gauvreau K, Marshal AC, McElhinney DB, Landzberg MJ. Durability of large diameter right ventricular outflow tract conduits in adults with congenital heart disease. Int J Cardiol. 2014;175(3):455-63.   

Freud LR, McElhinney DB, Marshall AC, Marx GR, Friedman KG, Del Nido PJ, Emani SM, Lafranchi T, Silva V, Wilkins-Haug LE, Benson CB, Lock JE, Tworetzky W. Fetal aortic valvuloplasty for evolving hypoplastic left heart syndrome: postnatal outcomes of the first 100 patients. Circulation. 2014 ;130(8):638-45.   

Beroukhim RS, Gauvreau K, Benavidez OJ, Baird CW, LaFranchi T, Tworetzky W. Perinatal Outcomes after Fetal Diagnosis of Single Ventricle Cardiac Defects. Ultrasound Obstet Gynecol. 2014.   

Friedman KG, Schidlow D, Freud L, Escobar-Diaz M, Tworetzky W. Left ventricular diastolic function and characteristics in fetal aortic stenosis. Am J Cardiol. 2014; 114(1):122-7.   

Opotowsky AR, Landzberg MJ, Earing MG, Wu FM, Triedman JK, Casey A, Ericson DA, Systrom D, Paridon SM, Rhodes J. Abnormal spirometry after the Fontan procedure is common and associated with impaired aerobic capacity. Am J Physiol Heart Circ Physiol. 2014;307(1):H110-7.   

Cheng HH, Wypij D, Laussen PC, Bellinger DC, Stopp CD, Soul JS, Newburger JW, Kussman BD. Cerebral blood flow velocity and neurodevelopmental outcome in infants undergoing surgery for congenital heart disease. Ann Thorac Surg. 2014 ;98(1):125-32.   

Costello JM, Dunbar-Masterson C, Allan CK, Gauvreau K, Newburger JW, McGowan FX Jr, Wessel DL, Mayer JE Jr, Salvin JW, Dionne RE, Laussen PC. Impact of empiric nesiritide or milrinone infusion on early postoperative recovery after Fontan surgery: a randomized, double-blind, placebo-controlled trial. Circ Heart Fail. 2014;7(4):596-604.   

Saleeb SF, Newburger JW, Geva T, Baird CW, Gauvreau K, Padera RF, Del Nido PJ, Borisuk MJ, Sanders SP, Mayer JE. Accelerated degeneration of a bovine pericardial bioprosthetic aortic valve in children and young adults. Circulation. 2014;130(1):51-60.   

Porras D, Brown DW, Rathod R, Friedman K, Gauvreau K, Lock JE, Esch JJ, Bergersen L, Marshall AC. Acute outcomes after introduction of a Standardized Clinical Assessment and Management Plan (SCAMP) for balloon aortic valvuloplasty in congenital aortic stenosis. Congenit Heart Dis. 2014 Jul;9(4):316-25.   

Giangregorio M, Mott S, Tong E, Handa S, Gauvreau K, Connor JA. Management of peripherally inserted central catheters (PICC) in pediatric heart failure patients receiving continuous inotropic support. J Pediatr Nurs. 2014;29(4):e3-9.   

Bautista-Hernandez V, Myers PO, Cecchin F, Marx GR, Del Nido P. Late left ventricular dysfunction after anatomic repair of congenitally corrected transposition of the great arteries. J Thorac Cardiovasc Surg. 2014;148(1):254-8.   

Nathan M, Sadhwani A, Gauvreau K, Agus M, Ware J, Newburger JW, Pigula F. Association between technical performance scores and neurodevelopmental outcomes after congenital cardiac surgery. J Thorac Cardiovasc Surg. 2014 Jul;148(1):232-237.e3. 

Nathan M, Sleeper LA, Ohye RG, Frommelt PC, Caldarone CA, Tweddell JS, Lu M, Pearson GD, Gaynor JW, Pizarro C, Williams IA, Colan SD, Dunbar-Masterson C, Gruber PJ, Hill K, Hirsch-Romano J, Jacobs JP, Kaltman JR, Kumar SR, Morales D, Bradley SM, Kanter K, Newburger JW; Pediatric Heart Network Investigators. Technical performance score is associated with outcomes after the Norwood procedure. J Thorac Cardiovasc Surg. 2014. pii: S0022-5223(14)00774-0.