Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension

NCT02988245 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Geneticure
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 15

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Number of Medication Changes

  1 year

Study Arms (2)

Genetically-Guided Treatment for HTN

EXPERIMENTAL

Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis.

Drug: Geneticure Panel for HTN therapy

JNC-8-Guided Treatment

ACTIVE COMPARATOR

Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis.

Drug: JNC-8

Interventions

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

Genetically-Guided Treatment for HTN

JNC-8 DRUG

Using JNC-8 guidelines to guide therapy

JNC-8-Guided Treatment

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Geneticure, LLC: lead
• Fairview Health Services: collaborator
• University of Minnesota: collaborator

Study Sites (15)

Fairview Health Clinics - Andover

Andover, Minnesota, 55304, United States

Location

Fairview Health Clinics - Blaine

Blaine, Minnesota, 55449, United States

Location

Fairview Health Clinics - Bloomington, Oxboro

Bloomington, Minnesota, 55420, United States

Location

Fairview Clinics - Brooklyn Park

Brooklyn Park, Minnesota, 55443, United States

Location

Fairview Clinics- Burnsville

Burnsville, Minnesota, 55337, United States

Location

Fairview Clinics - Columbia Heights

Columbia Heights, Minnesota, 55421, United States

Location

Fairview Health Clinics - Edina

Edina, Minnesota, 55345, United States

Location

Fairview Health Clinics - Elk River

Elk River, Minnesota, 55330, United States

Location

Fairview Clinics - Fridley

Fridley, Minnesota, 55432, United States

Location

Fairview Clinics - Lino Lakes

Lino Lakes, Minnesota, 55014, United States

Location

Fairview Clinics - Hiawatha

Minneapolis, Minnesota, 55406, United States

Location

Fairview Clinic - New Brighton

New Brighton, Minnesota, 55112, United States

Location

Fairview Clinics - North Branch

North Branch, Minnesota, 55056, United States

Location

Fairview Clinics - Wyoming

Wyoming, Minnesota, 55092, United States

Location

Fairview Health Services - Zimmerman

Zimmerman, Minnesota, 55398, United States

Location

Related Links

• Sponsor Site

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pamela Phelps, PharmD

  Fairview Health Services

  PRINCIPAL INVESTIGATOR

• Weihong Tang, MD, PhD

  University of Minnesota

  STUDY DIRECTOR

• Michael Schulenberg, MD

  Fairview Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric M Snyder, PhD

CONTACT

18003628109; eric@geneticure.com

Thomas P Olson, PhD

CONTACT

18003628109; tom@geneticure.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: June 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)