Preventive Cardiology clinical trials
A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. If your child’s doctor recommends participation in one of Children’s clinical trials, that likely means that the doctor believes that the plan outlined in that trial represents the absolute best, latest care your child can possibly receive.
As part of its mission to advance the scientific understanding of atherosclerosis—the gradual hardening and narrowing of arteries that sets the stage for a heart attack or stroke—the Preventive Cardiology Clinic participates in, and recruits for, a wide range of research programs. Our research is aimed at furthering the understanding of the mechanisms behind atherosclerosis, as well as studying more effective and safe treatments for cholesterol, triglycerides and high blood pressure problems in children. Coming to the clinic does not automatically include your child in a study, nor is this required for treatment.
Current clinical trials
At any given time, Children’s has hundreds of clinical trials underway. Clinical trials currently available through the Preventive Cardiology Clinic include:
Use of Omega-3s in Adolescents with Mild to Moderately Elevated Triglycerides: Hypertriglyceridemia is a known complication of obesity and an important element of the metabolic syndrome. The optimal treatment for hypertriglyceridemia in childhood is not well known. Individuals with diets high in fish have been shown to have lower rates of cardiovascular disease, and omega-3 fatty acid supplements have been shown to successfully lower triglyceride levels in adults. Clinicians at Children’s Hospital Boston are conducting a trial to evaluate the efficacy of omega-3 fatty acids compared to placebo (dummy pill) in reducing triglyceride levels in youth ages 12-19 years old whose baseline triglycerides range from150 mg/dl to 1000 mg/dl.
PowerUp study: This clinical trial evaluates two heart-healthy diets in the treatment of adolescents with some heart disease risk factors associated with being overweight, such as high systolic blood pressure, pre-diabetes, insulin resistance and cholesterol disorders.
Participants in the study receive most meals and snacks in an amount designed to induce weight loss for eight weeks, and then are followed via telephone nutrition counseling during a four-month maintenance phase. Food is delivered to participants’ homes; participants and their families receive nutritional counseling during the food delivery visits.
The goal is to test whether either eating strategy is better at improving heart disease risk factors. Testing for cardiovascular risk factors is performed, and the results are provided to participants and their primary care providers. Children between the ages of 8 and 17 with two or more cardiovascular risk factors, but no other major medical issues, who are willing and eager to follow a healthy diet, may be eligible to participate.
- Piloting an Interactive Fitness Program: Childhood obesity is an increasingly common risk factor for diabetes and cardiovascular disease (CVD). Research suggests exercise reduces cardiometabolic risk. Children’s Hospital Boston researchers are engaged in a collaborative feasibility project with researchers at UMass Boston’s GoKids facility and the children and staff at Russell Elementary School in Boston to assess whether an “exer-game” intervention improves levels of moderate or vigorous physical activity, CVD risk factors, fitness and self-perception in elementary school children. A Children’s Hospital Boston sub-study explores effects on lipids, insulin resistance, vascular reactivity and body composition. To be enrolled in this study, a child must be a student of Russell Elementary.