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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

Tracking Information
First Submitted Date  ICMJE December 7, 2016
First Posted Date  ICMJE December 9, 2016
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE January 23, 2017
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • Time to Blood Pressure Control [ Time Frame: 1 year ]
    Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension
Official Title  ICMJE Prospective Randomized Controlled Trial Investigating the Use of Genetic Predisposition to Guide Pharmacologic Therapy for Hypertension
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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
  • Drug: JNC-8
    Using JNC-8 guidelines to guide therapy
Study Arms  ICMJE
  • Experimental: Genetically-Guided Treatment for HTN
    Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis.
    Intervention: Drug: Geneticure Panel for HTN therapy
  • Active Comparator: JNC-8-Guided Treatment
    Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis.
    Intervention: Drug: JNC-8
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2019)
425
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2016)
800
Actual Study Completion Date  ICMJE March 31, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02988245
Other Study ID Numbers  ICMJE Geneticure
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Geneticure, LLC
Study Sponsor  ICMJE Geneticure, LLC
Collaborators  ICMJE
  • Fairview Health Services
  • University of Minnesota
Investigators  ICMJE
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
PRS Account Geneticure, LLC
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP