Current Research

Title: National Children’s Study Florida
Sponsor: National Institutes of Health/National Institute of Child Health and Human Development
Length: 9/26/08 – 9/25/14
Description: The National Children’s Study (NCS) will examine the effects of environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21. The goal of the study is to improve the health and well-being of children.

 

Title: Maximizing the Therapeutic Index of Childhood ALL
Sponsor: Dana Farber Cancer Institute/National Cancer Institute
Length: 9/27/06 – 4/30/11
Description: The hypothesis underlying this proposal is that improved outcomes will originate from laboratory investigation of the biology of ALL, leading to more specific therapies with less harmful effects of treatment.

 

Title: Genetic Mechanisms of Cardiotoxicity in Pediatric Cancer Survivors
Sponsor: National Institutes of Health/National Cancer Institute
Length: 9/28/07 – 8/31/10
Description: This study will determine the relationship between mitochondrial DNA and HFE mutations and chemotherapy-induced cardiac dysfunction in high-risk long-term pediatric Acute Lymphoblastic Leukemia survivors.

 

Title: Pediatric Cardiomyopathy Registry
Sponsor: National Institutes of Health/National Heart, Lung, and Blood Institute
Length: 6/1/05 – 5/31/10
Description: The primary specific aims are: 1. To confirm whether the regional, ethnic group, time gender, age, and type of cardiomyopathy differences in the incidence of cardiomyopathy observed in the PCMR are correct by prospectively capturing two distinct regions of the United States; 2. To determine whether baseline factors at diagnosis or trends over time predict outcomes of mortality, late abnormalities of ventricularstructure and function, congestive heart failure, listing for cardiac transplantation, or receiving a cardiac transplantation; 3. To assess the functional status of children with cardiomyopathy.

 

Title: Cardiovascular Status of HAART-Exposed Infants/Children
Sponsor: National Heart, Lung, and Blood Institute
Length: 9/30/02 – 7/31/09
Description: This study will determine the cardiovascular effects of HAART in seroreverters and the need for future cardiovascular follow-up and cardiovascular preventive and therapeutic trials in this rapidly expanding population.

 

Title: HAART Associated Cardiotoxicity in HIV Infected Children
Sponsor: National Institutes of Health/National Heart, Lung, and Blood Institute
Length: 8/1/04 – 7/31/09
Description: This multicenter national study funds activities similar to those proposed and will determine the cardiovascular effects of HAART in HIV-infected children and relate cardiac structure and function to the presence and type of mitochondrial DNA mutations. Drs. Walker and Lipshultz collaborate on this study.

 

Title: Pediatric Cardiomyopathy Specimen Repository
Sponsor: National Institutes of Health/National Heart, Lung, and Blood Institute
Length: 8/1/07 – 4/30/11
Description: The purpose of the repository is to obtain and maintain blood and myocardial tissue specimens from children enrolled in the Pediatric Cardiomyopathy Registry to define etiologies of clinical phenotypes and enable quality multicenter collaboration to better illuminate the mechanisms of cardiomyopathy in children.

 

Title: A Reference Lab for the Echocardiograms and Cardiac Biochemical Markers Obtained from Pharmacia and Upjohn Company’s Zinecard
Sponsor: Pharmacia & Upjohn A Pfizer Company
Length: 7/25/97 – 11/30/09
Description: Study objective is to determine whether Zinecard, a cardioprotectant, reduces the risk of cardiac failures when given with an increased dosage of adriamycin.

 

Title: Treatment of Childhood Lymphoblastic Leukemia
Sponsor: Pharmacia & Upjohn A Pfizer Company
Length: 7/25/97 – 11/30/09
Description: This study focuses on dexrazoxane cardioprotection in newly diagnosed children with ALL being treated with doxorubicin.

 

Title: Determination of the Effectiveness of Dexrazoxane as a Cardioprotectant in Long-Term Survivors of Leukemia Treated with Anthracycline
Sponsor: Women Cancer Association
Length: 6/1/2005 – 5/31/09
Description: Study will seek to determine sub populations most likely to benefit from Dexrazoxane, whether there is less toxicity from using this drug before chemotherapy, whether it results in less doxorubicin related DNA mutations and whether this is an issue in children carrying the hemochromatosis gene.

 

Title: Reduction of Doxorubicin Cardiotoxicity in Long Term Survivors of Childhood Leukemia by using Dexrazoxane
Sponsor: Women Cancer Association
Length: 6/1/08 – 5/31/09
Description: Study will seek to determine sub populations most likely to benefit by use of Dexrazoxane, whether there is less toxicity and late effects based on using dexrazoxane before doxorubicinin childhood leukemia chemotherapy, whether this is related to reduction of doxorubicin-related DNA mutations in the heart muscle’s energy system, and whether there is more of an issue in children who carry the hemochromatosis gene that results in more iron-doxorubicin free radical damage.

 

Title: Treatment of Acute Lymphoblastic Leukemia
Sponsor: Novartis
Length: 6/1/05 – 6/30/09
Description: Study reviews oncologic outcomes of relapse and second malignancies with the cardiac outcomes of off therapy echocardiographic assessment of cardiac structure and function.

 

Title: Baseline Predictors of Outcomes of Pediatrics Dilated Cardiomyopathy
Sponsor: National Institutes of Health/National Heart, Lung and Blood Institute
Length: 8/19/08 – 8/18/09
Description: Study will capitalize on the pre-existing, robust database from the Pediatric Cardiomyopathy Registry (PCMR), which contains baseline clinical and demographic information, as well as extensive longitudinal follow-up. Results of this study will greatly enhance the clinician’s ability to interpret the risk of death, trans-plant, or long-term survival for a child with dilated cardiomyopathy (DCM).

 

Title: Growth Patterns and Serial Echocardiographic Measures to Determine Outcomes in Children with Cardiomyopathy
Sponsor: Pediatric Cardiomyopathy Foundation
Length: 4/30/08 – 4/30/09
Description: This study will assess retrospective and prospective echocardiogram data to predict risk for pediatric cardiomyopathy patients.

 

Title: Exercise Intervention in a Pediatric Population with Cardiomyopathy.
Sponsor: Children’s Cardiomyopathy Foundation
Length: 12/19/05 – 12/31/09
Description: This study objective is to prove that supervised exercise regimens will improve cardiac function, body composition and quality of life for children with cardiomyopathy.

 

Title: Vascular Inflammation in Pediatric Cancer Survivors
Sponsor: Women’s Cancer Association of the University of Miami
Length: 6/1/07 – 5/31/09
Description: To determine the extent of vascular inflammation that may contribute to cardiovascular risk in pediatric cancer survivors.

 

Title: Vascular Inflammation and Endothelial Dysfunction and Response to Exercise in HIV-Infected Children
Sponsor: Micah Batchelor
Length: 1/1/07 – 12/31/09
Description: This is a study to understand the extent of vascular abnormalities and potential risk factors for them in HIV-infected children. This study also determines the role that a structured exercise program plays on decreasing vascular inflammatory and adhesion factors in HIV-infected children.

 

Title: Pediatric HIV/AIDS Cohort Study (PHACS) Coordinating Center
Sponsor: National Institutes of Health
Length: 9/30/05 – 7/31/10
Description: Part of the core scientific committee to develop prospective protocols studying several clinical outcomes in children with HIV infection or who were exposed to HIV.

 

Title: A Single-Dose Study to Assess the Pharmacokineticks, Safety, and Tolerability of Sitagliptin in Adolescents
Sponsor: Merck
Length: 8/8/08 – 8/07/12
Description: The purpose of this study is to give sitagliptin (Januvia™) to people between the ages of 10 and 17 years old who have Type 2 diabetes to see if it is safe, if they can tolerate the drug, and to measure the amount of sitagliptin in their blood over a period of time.

 

Title: Atherosclerotic Risk and Response to Exercise Intervention in HIV+ Children
Sponsor: National Heart, Lung and Blood Institute
Length: 9/25/08 – 6/30/11
Description: Through this study we will determine the extent of vascular dysfunction and its associations with metabolic parameters and will determine whether a structured exercise program positively changes these abnormalities in HIV-infected children.

 

Title: A Phase I/II Study of the Safety and Pharmacokinetics of Opebacan (rBPI₂₁) in Patients Undergoing HSCT
Sponsor: Xoma Corporation
Length: 4/16/07 – 4/15/10
Description: This study will demonstrate the safety of escalating doses of opebacan in patients undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transportation (HSCT) and will develop preliminary descriptive data on the occurrence and severity of HSTC-related complications.

 

Title: Sleep Studies in HIV+ Older Children/Adolescents
Sponsor: Baylor/National Institutes of Health
Length: 7/1/06 – 6/30/09
Description: This study examines the effects of HIV-1 infection upon the sleep-regulating pathways of the neuroendocrine-immune pathways that accelerate HIV-1 disease progression and contribute to the loss of neurocognitive function and general debilitation of children infected with HIV-1 perinatally or through risky adult-type behavior.

 

Title: Multivariate Regression Analysis and Logistic Modeling of Early Predictors of Trauma Patient Outcomes
Sponsor: U.S. Army Medical Research and Materiel Command / U.S. Army Institute of Surgical Research
Length: 9/15/08 – 9/14/09
Description: Provide services to USAISR in the form of consulting, training, data analysis, and scientific collaboration. Serve as a scientific consultant for biostatistical analysis of early indicators of trauma patient outcome for the USAISR.

 

Title: University of Miami Basic and Translational Research Program (BTRP) in Sickle Cell Disease.
Sponsor: National Institutes of Health/National Heart, Lung and Blood Institute
Length: 6/15/08 – 3/31/12
Description: This comprehensive sickle cell program includes a core, a scholar program, and a funded patient outcomes project, along with a summer science program.

 

Title: Pediatric Oral Health Care (PATCH)
Sponsor: Children’s Trust Foundation
Length: 7/1/08 – 6/30/09
Description: The primary aim of this study is to provide oral screening and fluoride varnish to underserved children ages 1-5 years in Miami-Dade County as well as provide training to pediatric residents and faculty on child oral healthier screening and fluoride varnish applications.  Survey data will be collected from parents regarding dental and eating behaviors of their children.  This data will be correlated with oral screening outcomes.