Hypertension is one of the most important preventable contributors to disease and death in the United States and represents the most common condition seen in the primary care setting. Approximately 78 million adults living in the U.S. have hypertension with more than 5 million new diagnoses made each year. Unfortunately, despite a significant impulse in the medical community to move towards an "individualized medicine" approach to patient centered treatment, the current clinical treatment strategy is based on a set algorithm which does not take into account individual patient differences. As a result hypertension is often sub-optimally treated based on "population averages", rather than a person's genetic make-up, with significant burden on our health care system. In fact, 40% of patients who are adherent to their blood pressure therapy (taking their medicines as prescribed by their clinician) do not have their blood pressure under control. Previous work has demonstrated significant functional polymorphisms within the kidney, vessels, and heart that will likely predict a patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a retrospective design, has determined that the addition of genetic knowledge to prescribing can improve therapeutic guidance and decrease the time to blood pressure control significantly. Despite this, to date, there are no prospective trials to guide blood pressure therapy using multiple organ systems that are important in the three most common classes of drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension in newly diagnosed patients.
Specific Aim: To determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension, when compared to conventional standard of care (JNC 8 guideline directed therapy). Hypothesis A: Patients randomized to genetically guided blood pressure therapy will have significantly reduced time to optimal blood pressure control compared to conventional standard of care. Hypotheses B: Patients randomized to genetically guided blood pressure therapy will have significantly greater absolute blood pressure reduction compared to conventional standard of care. Hypothesis C: Patients randomized to genetically guided blood pressure therapy will have to take fewer classes of blood pressure medicines in order to achieve blood pressure control. Secondary Aim: To determine if genetically guided blood pressure therapy reduces number of medication changes in patients with hypertension. Hypotheses: Patients randomized to genetically guided blood pressure therapy will have significantly less medication changes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,000
Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension
Using JNC-8 guidelines to guide therapy
Fairview Health Clinics - Andover
Andover, Minnesota, United States
Fairview Health Clinics - Blaine
Blaine, Minnesota, United States
Fairview Health Clinics - Bloomington, Oxboro
Bloomington, Minnesota, United States
Fairview Clinics - Brooklyn Park
Brooklyn Park, Minnesota, United States
Fairview Clinics- Burnsville
Burnsville, Minnesota, United States
Fairview Clinics - Columbia Heights
Columbia Heights, Minnesota, United States
Fairview Health Clinics - Edina
Edina, Minnesota, United States
Fairview Health Clinics - Elk River
Elk River, Minnesota, United States
Fairview Clinics - Fridley
Fridley, Minnesota, United States
Fairview Clinics - Lino Lakes
Lino Lakes, Minnesota, United States
...and 5 more locations
Time to Blood Pressure Control
Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing
Time frame: 1 year
Change in Blood Pressure
Change (absolute) in BP (systolic, SBP, diastolic, DBP, and mean arterial, MAP) between genetically-guided prescribing and JNC-8 guided prescribing
Time frame: 1 year
Number of Blood Pressure Medicines
Number of blood pressure medicines needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
Time frame: 1 year
Number of Medication Changes
Number of blood pressure medicine changes needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.