Cincinnati Children's is conducting a research study, sometimes known as a clinical trial or clinical study, to find out if a drug, called pitavastatin, used to lower cholesterol can improve artery health in children and teens who are overweight with high blood lipids (cholesterol and fats). These children and teens may have a condition known as combined dyslipidemia of obesity (CDO).
CDO is abnormal levels of blood lipids that may occur in people who are overweight. When people have CDO for many years, the lipids may build-up in the arteries, causing them to thicken and narrow (called atherosclerosis). This can then lead to serious health problems later in life, such as heart attack or stroke.
This is a Pediatric Heart Network (PHN) research study. The PHN is a group of hospitals in the US and Canada that conducts research studies in children with heart disease and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health.
Children and teens, 10 to 18 years old, who are overweight and have high cholesterol may be eligible for participation.
If your child qualifies for this study and you decide you want him/her to participate, your child will come to Cincinnati Children’s 7 times over the next 2 years. Study visits will last between 1 and 3 hours.
The following will happen during one or more study visits:
You and your child will be given a parental permission form/child assent form, which explain the details of the study, to review and sign. A member of the research team will review the forms with you and your child and will be sure all your questions are answered.
Your child will first come to Cincinnati Children’s for a screening visit, which will determine whether or not he/she qualifies for this study.
If your child qualifies, he/she will be scheduled for a baseline visit (within 6 weeks of the screening visit). During this visit, your child will be "randomized" (by chance, like flipping a coin) into one of 2 study drug groups to receive either:
You and your child will be taught how to take his/her assigned study drug, which will be in the form of a pill. Your child will take the study drug once a day by mouth for 2 years. It is important that your child takes the study drug as instructed.
At the end of the visit, you will be given enough of your child’s study drug to last until the next study visit (the study drug may also be mailed to you).
There will be 5 more study visits after the baseline visit, typically 6 months apart. At each of these visits, your child will complete some tests and procedures and the research team will ask about side effects and/or health problems. You will also need to return all unused or leftover study drug to the research team to be counted at each of the visits.
When all participants in the study have finished their 2 years of study drug, the research team will find out what study group your child was in and will tell you and your child’s doctor.
Being in this study may or may not help your child right now. If your child is randomized to receive pitavastatin, it is possible that his/her lipid levels could improve. However, we cannot guarantee or promise this will happen.
When we finish the study, we hope to know more about how to treat children with CDO. This may help other children with CDO later on.There are some possible risks and side effects associated with this study and study drug. All possible risks will be discussed with you if you are interested in learning more about the study.
Participants will receive up to $550 and parents/guardians will receive up to $325 for their time and travel. Participants will also receive a welcome bag containing items such as a water bottle, cookbook and fitness tracker which will be theirs to keep at the end of the study.
PHN Coordinator
marisa.almaguer@cchmc.org
513-498-6919
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Amy S. Shah, MD, MS
Cincinnati Children’s Hospital Medical Center
Cardiology Clinic
Heart Institute