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Trial record 2 of 4 for:    geneticure

Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension (PGEN for HTN)

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ClinicalTrials.gov Identifier: NCT02988245
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
Fairview Health Services
University of Minnesota
Information provided by (Responsible Party):
Geneticure, LLC

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Geneticure Panel for HTN therapy Drug: JNC-8 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Investigating the Use of Genetic Predisposition to Guide Pharmacologic Therapy for Hypertension
Actual Study Start Date : January 23, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Genetically-Guided Treatment for HTN
Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis.
Drug: Geneticure Panel for HTN therapy
Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension

Active Comparator: JNC-8-Guided Treatment
Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis.
Drug: JNC-8
Using JNC-8 guidelines to guide therapy




Primary Outcome Measures :
  1. Time to Blood Pressure Control [ Time Frame: 1 year ]
    Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing

  2. Change in Blood Pressure [ Time Frame: 1 year ]
    Change (absolute) in BP (systolic, SBP, diastolic, DBP, and mean arterial, MAP) between genetically-guided prescribing and JNC-8 guided prescribing

  3. Number of Blood Pressure Medicines [ Time Frame: 1 year ]
    Number of blood pressure medicines needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing


Secondary Outcome Measures :
  1. Number of Medication Changes [ Time Frame: 1 year ]
    Number of blood pressure medicine changes needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988245


Locations
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United States, Minnesota
Fairview Health Clinics - Andover
Andover, Minnesota, United States, 55304
Fairview Health Clinics - Blaine
Blaine, Minnesota, United States, 55449
Fairview Health Clinics - Bloomington, Oxboro
Bloomington, Minnesota, United States, 55420
Fairview Clinics - Brooklyn Park
Brooklyn Park, Minnesota, United States, 55443
Fairview Clinics- Burnsville
Burnsville, Minnesota, United States, 55337
Fairview Clinics - Columbia Heights
Columbia Heights, Minnesota, United States, 55421
Fairview Health Clinics - Edina
Edina, Minnesota, United States, 55345
Fairview Health Clinics - Elk River
Elk River, Minnesota, United States, 55330
Fairview Clinics - Fridley
Fridley, Minnesota, United States, 55432
Fairview Clinics - Lino Lakes
Lino Lakes, Minnesota, United States, 55014
Fairview Clinics - Hiawatha
Minneapolis, Minnesota, United States, 55406
Fairview Clinics - North Branch
N. Branch, Minnesota, United States, 55056
Fairview Clinic - New Brighton
New Brighton, Minnesota, United States, 55112
Fairview Clinics - Wyoming
Wyoming, Minnesota, United States, 55092
Fairview Health Services - Zimmerman
Zimmerman, Minnesota, United States, 55398
Sponsors and Collaborators
Geneticure, LLC
Fairview Health Services
University of Minnesota
Investigators
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Principal Investigator: Pamela Phelps, PharmD Fairview Health Services
Study Director: Weihong Tang, MD, PhD University of Minnesota
Principal Investigator: Michael Schulenberg, MD Fairview Health Services

Additional Information:
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Responsible Party: Geneticure, LLC
ClinicalTrials.gov Identifier: NCT02988245    
Other Study ID Numbers: Geneticure
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases