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| Name | Class |
|---|---|
| Fairview Health Services | OTHER |
| University of Minnesota | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genetically-Guided Treatment for HTN | Experimental | Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis. |
|
| JNC-8-Guided Treatment | Active Comparator | Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geneticure Panel for HTN therapy | Drug | Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Blood Pressure Control | Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing | 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 | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric M Snyder, PhD | Contact | 18003628109 | 702 | eric@geneticure.com |
| Thomas P Olson, PhD | Contact | 18003628109 | 703 | tom@geneticure.com |
| Name | Affiliation | Role |
|---|---|---|
| Pamela Phelps, PharmD | Fairview Health Services | Principal Investigator |
| Weihong Tang, MD, PhD | University of Minnesota | Study Director |
| Michael Schulenberg, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairview Health Clinics - Andover | Andover | Minnesota | 55304 | United States | ||
| Fairview Health Clinics - Blaine |
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| Label | URL |
|---|---|
| Sponsor Site | View source |
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| JNC-8 | Drug | Using JNC-8 guidelines to guide therapy |
|
| Fairview Health Services |
| Principal Investigator |
| Blaine |
| Minnesota |
| 55449 |
| United States |
| Fairview Health Clinics - Bloomington, Oxboro | Bloomington | Minnesota | 55420 | United States |
| Fairview Clinics - Brooklyn Park | Brooklyn Park | Minnesota | 55443 | United States |
| Fairview Clinics- Burnsville | Burnsville | Minnesota | 55337 | United States |
| Fairview Clinics - Columbia Heights | Columbia Heights | Minnesota | 55421 | United States |
| Fairview Health Clinics - Edina | Edina | Minnesota | 55345 | United States |
| Fairview Health Clinics - Elk River | Elk River | Minnesota | 55330 | United States |
| Fairview Clinics - Fridley | Fridley | Minnesota | 55432 | United States |
| Fairview Clinics - Lino Lakes | Lino Lakes | Minnesota | 55014 | United States |
| Fairview Clinics - Hiawatha | Minneapolis | Minnesota | 55406 | United States |
| Fairview Clinic - New Brighton | New Brighton | Minnesota | 55112 | United States |
| Fairview Clinics - North Branch | North Branch | Minnesota | 55056 | United States |
| Fairview Clinics - Wyoming | Wyoming | Minnesota | 55092 | United States |
| Fairview Health Services - Zimmerman | Zimmerman | Minnesota | 55398 | United States |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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