Clinical trial NCT02988245: Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension
Official title: Prospective Randomized Controlled Trial Investigating the Use of Genetic Predisposition to Guide Pharmacologic Therapy for Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Geneticure, LLC
Sponsor class: INDUSTRY
Collaborators: name: Fairview Health Services
name: University of Minnesota
First posted: 2016-12-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject with new diagnosis of hypertension or uncontrolled hypertension and on one medication
2. Subject is able and willing to provide informed consent
3. Subject is ≥ 30 and ≤ 80 years of age
4. Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 50

Exclusion Criteria:

1. Subject has been diagnosed with chronic kidney disease as determined by serum creatinine levels of \>1.3 mg/dl for men and \>1.1 for women.
2. Subject has clinically significant cardiac disease as determined by diagnosed coronary artery disease, diagnosed heart failure, and congenital cardiac disease.
3. Subject has clinically significant vascular disease as determined by diagnosed peripheral vascular disease and diagnosed pulmonary hypertension.
4. Liver dysfunction is defined using the normal reference range for lower limit of normal and upper limit of normal used by Fairview labs and as determined by diagnosed liver disease /cirrhosis as listed in the patient's problem list based on ICD-10.
5. Subject has secondary hypertension.
6. Subject has prior diagnosis of endocrine disorders except uncomplicated type 2 diabetes and well controlled hypothyroidism.
7. Subject is pregnant.
8. Subject is breastfeeding.
9. Subject becomes pregnant during study
10. Subjects lacking the capacity to consent

Primary outcomes:
measure: Time to Blood Pressure Control
timeFrame: 1 year
measure: Change in Blood Pressure
timeFrame: 1 year
measure: Number of Blood Pressure Medicines
timeFrame: 1 year
Secondary outcomes:
measure: Number of Medication Changes
timeFrame: 1 year
Other outcomes:
Locations:
city: Andover
country: United States
facility: Fairview Health Clinics - Andover
state: Minnesota
city: Blaine
country: United States
facility: Fairview Health Clinics - Blaine
state: Minnesota
city: Bloomington
country: United States
facility: Fairview Health Clinics - Bloomington, Oxboro
state: Minnesota
city: Brooklyn Park
country: United States
facility: Fairview Clinics - Brooklyn Park
state: Minnesota
city: Burnsville
country: United States
facility: Fairview Clinics- Burnsville
state: Minnesota
city: Columbia Heights
country: United States
facility: Fairview Clinics - Columbia Heights
state: Minnesota
city: Edina
country: United States
facility: Fairview Health Clinics - Edina
state: Minnesota
city: Elk River
country: United States
facility: Fairview Health Clinics - Elk River
state: Minnesota
city: Fridley
country: United States
facility: Fairview Clinics - Fridley
state: Minnesota
city: Lino Lakes
country: United States
facility: Fairview Clinics - Lino Lakes
state: Minnesota
city: Minneapolis
country: United States
facility: Fairview Clinics - Hiawatha
state: Minnesota
city: N. Branch
country: United States
facility: Fairview Clinics - North Branch
state: Minnesota
city: New Brighton
country: United States
facility: Fairview Clinic - New Brighton
state: Minnesota
city: Wyoming
country: United States
facility: Fairview Clinics - Wyoming
state: Minnesota
city: Zimmerman
country: United States
facility: Fairview Health Services - Zimmerman
state: Minnesota
Study officials:
affiliation: Fairview Health Services
name: Pamela Phelps, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Weihong Tang, MD, PhD
role: STUDY_DIRECTOR
affiliation: Fairview Health Services
name: Michael Schulenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: