Needed: Teens 13 to 17 Years Old Who Have Normal or High Blood Pressure

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 teens with normal, mid and high blood pressure.

Who can participate?

Teens, 13 to 17 years old, who have normal (healthy) or high blood pressure, may be eligible for participation.

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.

Conditions

  • Healthy Babies Children and Teens
  • Hypertension - High Blood Pressure

What will happen in the study?

If your teen 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 teen 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 teen.

The following procedures will happen while your teen is in this research study: 

    • Collect demographics - your teen’s 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 your teen’s genes influence his or her blood pressure
    • Previous blood pressure recording – study staff will record your teen’s blood pressure from his or her 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 with you to your teen’s next study visit 
    • Echocardiogram – this is an ultrasound picture of your teen’s 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, which will record the time it takes for blood to flow to the heart and to other sites in the body
    • Questionnaires for cognitive function (brain function), sleep habits, physical activity and diet 

During the regular research study visit, study staff will also provide you and your teen with instructions on how to use the ambulatory blood pressure monitor (a cuff that your teen 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 teen right now. We will send you the results of your teen’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.

What are the bad things that can happen from this research?

There are low risks associated with this research study. Possible risks and side effects will be provided to and discussed with those participants, parents or guardians interested in knowing more about this study.

Will you/your child be paid to be in this research study?

Participants may receive up to $125 for their time and travel.

Contact

Contact Us.Study Coordinator
SHIPAHOYStudy@cchmc.org
513-803-0366
Cincinnati Children’s Hospital Medical Center
Heart Institute
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Elaine Urbina, MD
Director, Preventative Cardiology
Cincinnati Children’s Hospital Medical Center
Heart Institute