Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about how high blood pressure in teens affects the risk for cardiovascular injury later in life.
We will compare study results of children and teens with normal, mid and high blood pressure.
Who can participate?
Children and teens, 11 to 18 years old, who have mid or high blood pressure levels, or are at risk for higher blood pressure, may be eligible for participation.
Children and teens who are taking medicine to control his or her blood pressure; type 1 or type 2 Diabetes; or cholesterol may NOT be able to participate.
What will happen in the study?
If your child qualifies for this study and you decide you want them to participate, you will come to Cincinnati Children’s for 2 to 4 study visits. The study can be completed in as few as 3 days or as long as 6 months, depending on scheduling availability for the visits.
Your child will have a blood pressure-only visit as well as a regular research study visit. The regular research study visit can be conducted during 1 visit or can be split into 2 visits if that is easier to schedule for you or your child.
The following procedures will happen during this research study:
- Collect demographics - age, gender
- Medical and family history
- Height and body weight measurements
- Vital sign measurements
- Urine samples for lab tests
- Pregnancy test, if female
- Blood samples for lab tests and genetic evaluation - to see how lifestyle (diet and exercise) affects the way genes influence blood pressure
- Previous blood pressure recording – study staff will record blood pressure from your child’s last clinic visit and use it as part of our research records
- 8 seated blood pressure readings
- Study questionnaires – sent home with you to fill out and bring back to your child’s next study visit
- Echocardiogram – an ultrasound picture of the heart
- Blood vessel tests for pulse wave velocity – a test performed by placing a pressure sensor the size and shape of a pencil (without using needles or radiation), on the neck and leg pulse points and recording the time it takes for blood to flow to the heart and to other sites in the body
- Questionnaires: cognitive function (brain function), sleep habits, physical activity and diet
During the regular research study visit, study staff will also provide you and your child with instructions on how to use the ambulatory blood pressure monitor (a cuff that your child will wear placed around the upper arm for 24 hours) as well as instructions on how to return the monitor to Cincinnati Children’s when the study is finished.
You, as a participant or as a parent/guardian, will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the good things that can happen from this research?
Being in this study may or may not help your child right now. We will send you the results of your child’s laboratory blood testing, which may be helpful to you for his or her care. However, we will not send you the results of the genetic testing.
When we finish the study, we hope that we will know more about how blood pressure affects the risk for cardiovascular events later in life. This may also help children with high blood pressure later on.