PGen Study for Hypertension Treatment

Why is the PGen Study Important?

Hypertension, or high blood pressure, is one of the most preventable causes of heart disease and death in the U.S. And it is incredibly common – about 1 in 3 adults have it. Treatment includes a lifestyle changes, like weight loss and increased activity, but many people also need medication to manage their blood pressure.

Several Fairview Clinics are partnering with a company called Geneticure, a pharmacogentics testing company, to conduct a research study to assess whether a DNA test can help determine which hypertension medications your body would respond to best.

To learn more about the study, watch this short video:

What does the study involve?

A DNA sample will be collected by swabbing your cheek. Your DNA is only used for this study.

Patients will be put into random groups that either receive medication based on DNA or receive medication based on standard of care for the treatment of hypertension. Participants must commit to eight visits during the course of a year at one of the participating clinic locations.

Patients with uncontrolled hypertension will be asked to discontinue all hypertension medications for four weeks prior to starting newly recommended medications. You’ll also be asked to monitor your blood pressure twice daily using provided home blood pressure cuffs.

For each of the follow-up visits your blood pressure will be taken. You will also be asked to complete surveys before each follow-up visit. Your waist circumference will be measured at your first study visit, last study visit, and possibly at some of your follow-up visits.

Compensation and cost

Those enrolled will receive $100 for attending all study visits and completing all post-visit surveys. Study visits scheduled after consent are provided at no cost to patients. Visits in which patient is diagnosed with hypertension will be billed to patient’s insurance.

Any tests conducted, medications prescribed, or additional, non-study visits scheduled for hypertension during enrollment will be billed to patient’s insurance (blood test, urine test, etc.)

Study Visit Schedule

Visit 1: The start of your study participation
Prescribed Medication: 4 weeks after Visit 1
Visit 2: 6 weeks after Visit 1
Visit 3: 4 weeks after Visit 2
Visit 4: 4 weeks after Visit 3
Visit 5: 6 weeks after Visit 4
Visit 6: 6 weeks after Visit 5
Visit 7: 12 weeks after Visit 6
Visit 8: 16 weeks after Visit 7. Final clinic visit

Are you eligible to participate?

To be eligible, you need to meet all of the following criteria:

  • Between the ages of 30 and 80
  • BMI between 19 and 50
  • Have a diagnosis of uncontrolled hypertension OR be a newly diagnosed hypertensive patient
  • For uncontrolled hypertensive patients, you can only be on one class of medication and need to have had uncontrolled hypertension for at least 2 of your last 3 blood pressure readings
  • No diagnosis of the following conditions:
    • Cardiac disease
    • Secondary hypertension/preeclampsia
    • Vascular disease
    • Chronic kidney disease
  • You are not eligible for this study if you are pregnant or breastfeeding

To enroll or learn more about the study please call 651-643-0295 or email pgenstudy@fairview.org.

Participating locations

The PGen Study is currently being conducted at the following clinics:

Metro
  • Fairview Clinics - Brooklyn Park
  • Fairview Clinics - Columbia Heights
  • Fairview Clinics –Edina
  • Fairview Clinics – Fridley
  • Fairview Clinics - Hiawatha
  • Fairview Clinics – New Brighton
North Region
  • Fairview Clinics – Andover
  • Fairview Clinics - Blaine
  • Fairview Clinics - Elk River
  • Fairview Clinics - Lino Lakes
  • Fairview Clinics - North Branch
  • Fairview Clinics – Wyoming
  • Fairview Clinics - Zimmerman
South Region
  • Fairview Clinics – Burnsville
  • Fairview Clinics – Bloomington, Oxboro
Additional locations may be added in the future.

Study Expectations and Materials

If you want to read more detail about the study to better understand things like, duration of the study, length of the visits, what’s expected of enrollees before and after completing office visits, how hypertension medications are managed, patient privacy and much more take a look at the documents below.

Documents
Consent document 
Patient expectations document –subject w/ new Hypertension diagnosis 
Patient expectations document –subject w/ existing Hypertension diagnosis 
HIPAA 
Family History Questionnaire form 

Schedule enrollment visit

If you believe you have high blood pressure and meet study criteria you can schedule an enrollment visit today by calling 651-643-0295.

More information

Pamela Phelps, Pharm.D., FASHP, is the principle investigator of this study and may be reached at pgenstudy@fairview.org. To learn more about Geneticure, please visit geneticure.com. You may look up the PGen Study on the https://clinicaltrials.gov/ database. The Clinical Trials Identifier for the PGen Study is: NCT02988245.