Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension

Status unconfirmed · Phase 2

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID: NCT02988245
Run by: Geneticure, LLC
People needed: 1000
Starts: 2022-06-01
Expected to finish: 2023-12-01
Last updated by the study team: 2022-02-02

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.
Subject has clinically significant cardiac disease as determined by diagnosed coronary artery disease, diagnosed heart failure, and congenital cardiac disease.
Subject has clinically significant vascular disease as determined by diagnosed peripheral vascular disease and diagnosed pulmonary hypertension.
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.
Subject has secondary hypertension.
Subject has prior diagnosis of endocrine disorders except uncomplicated type 2 diabetes and well controlled hypothyroidism.
Subject is pregnant.
Subject is breastfeeding.
Subject becomes pregnant during study
Subjects lacking the capacity to consent

Where it is running

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
Fairview Clinics - Hiawatha — Minneapolis, Minnesota, United States
Fairview Clinic - New Brighton — New Brighton, Minnesota, United States
Fairview Clinics - North Branch — North Branch, Minnesota, United States
Fairview Clinics - Wyoming — Wyoming, Minnesota, United States
Fairview Health Services - Zimmerman — Zimmerman, Minnesota, United States

Full record on ClinicalTrials.gov

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