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Relationship Between Genes Important in Blood Pressure Regulation and Blood Pressure Therapy in Hypertension

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ClinicalTrials.gov Identifier: NCT02524873
Recruitment Status : Completed
First Posted : August 17, 2015
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Geneticure, LLC

Brief Summary:
Whether patients with a functional genotype of a protein important in blood pressure regulation respond better to a drug therapy class/combination of therapy classes that target that specific pathway using the Geneticure panel for high blood pressure

Condition or disease Intervention/treatment
Hypertension Device: Geneticure Collection Kit for Pharmaocogenetics of Hypertension

Detailed Description:

2.1 Study Design and Protocol Overview This is a post-hoc association study of patients who have been diagnosed with high blood pressure and have been stable on medication treatment for at least 6 months. The purpose of this study is to evaluate the relationship between optimal medication therapy (or the therapy that has resulted in the most stable blood pressure for that particular patient) and the predicted optimal medication therapy based on a patient's genetic profile.

Chart reviews for the patient's history of antihypertensive therapy will be coupled with buccal swabs and blood pressure readings collected from eligible patients who have provided informed consent. The swab will be analyzed for fourteen genetic variants that are associated with antihypertensive therapy response (efficacy, side-effects).

2.2 Study Objective To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted.

2.3 Secondary Objectives

  • To assess the clinical time to achieve optimal blood pressure treatment.
  • To assess the number of office visits required to achieve optimal blood pressure treatment.

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Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of the Relationship Between Genes That Encode Proteins Important in Blood Pressure Regulation and Blood Pressure Therapy in Patients With Hypertension
Study Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Geneticure Collection Kit for Pharmaocogenetics of Hypertension
    Buccal (cheek) swab kit for DNA collection for analysis of genes for hypertension


Primary Outcome Measures :
  1. Ambulatory blood pressure changes (using sphygmomanometry) in response to therapy according to genes important in blood pressure regulation [ Time Frame: one year ]
    To assess the relationship between the drug therapy class/combination of therapy classes that resulted in the best blood pressure control for a patient vs. what the Geneticure high blood pressure panel would have predicted. We will assess blood pressure values (systolic and diastolic blood pressure, in mmHg) at rest in patients on different blood pressure medications.


Secondary Outcome Measures :
  1. The clinical time to achieve optimal blood pressure treatment [ Time Frame: One year ]
  2. The number of office visits required to achieve optimal blood pressure treatment. [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hypertension
Criteria

Inclusion Criteria:

  1. Subject is able and willing to provide informed consent
  2. Subject is ≥ 30 and ≤ 70 years of age
  3. Subject with diagnosis of Hypertension for a minimum of 1 year
  4. Subject has been on the same class/classes of blood pressure medication for a minimum of 6 months. Note: A change in dosage, frequency, or specific medication is acceptable as long as there have been no changes to the class/classes of medications prescribed.
  5. Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 35
  6. Subject is currently prescribed and taking one of the following classes of medications alone or in combination with each other or a Ca+ channel blocker.

    • Diuretics
    • ACE Inhibitors
    • Angiotensin Receptor Blocker (ARB)
    • Beta-blockers

Exclusion Criteria:

  1. Subject has clinically significant kidney disease as determined by the investigator.
  2. Subject has clinically significant cardiac disease as determined by the investigator.
  3. Subject has clinically significant vascular disease as determined by the investigator.
  4. Subject has a diagnosis of secondary hypertension or is experiencing a complication of pregnancy.
  5. Subject is currently prescribed and taking any additional class of medication(s) for high blood pressure not included in the list above, with the exception of a Ca+ channel blocker.
  6. Subject has Systolic BP > 190 or Diastolic BP > 120 documented within the six months prior to visit.
  7. Subject has a regular alcohol intake of greater than 21 units per week in the past 6 months
  8. Subject has smoked greater than two packs of cigarettes (total) or equivalent nicotine intake in the past 6 months.
  9. Subject has an anticipated survival less than 12 months.
  10. Any other reason that the subject is inappropriate for study enrollment in the opinion of the Investigator.

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): NCT02524873


Sponsors and Collaborators
Geneticure, LLC
Investigators
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Study Director: Krista Kleve RCRI
Publications of Results:
Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Multi-Gene Pharmacogenetics and Blood Pressure Control in Patients with Hypertension. The FASEB Journal 30:942.1. 2016
Johnson MW, Sprissler R, Olson TP, Beenken GW, Snyder EM. Time to Blood Pressure Control According to Drug Class in Patients with Hypertension. The FASEB Journal 30:941.12. 2016.

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Responsible Party: Geneticure, LLC
ClinicalTrials.gov Identifier: NCT02524873    
Other Study ID Numbers: GTC01
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases