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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

Tracking Information
First Submitted Date August 10, 2015
First Posted Date August 17, 2015
Last Update Posted Date March 21, 2017
Study Start Date April 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 14, 2015)
  • The clinical time to achieve optimal blood pressure treatment [ Time Frame: One year ]
  • The number of office visits required to achieve optimal blood pressure treatment. [ Time Frame: One year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Between Genes Important in Blood Pressure Regulation and Blood Pressure Therapy in Hypertension
Official Title Assessment of the Relationship Between Genes That Encode Proteins Important in Blood Pressure Regulation and Blood Pressure Therapy in Patients With Hypertension
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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with hypertension
Condition Hypertension
Intervention Device: Geneticure Collection Kit for Pharmaocogenetics of Hypertension
Buccal (cheek) swab kit for DNA collection for analysis of genes for hypertension
Study Groups/Cohorts Not Provided
Publications *
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 14, 2015)
99
Original Actual Enrollment Same as current
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02524873
Other Study ID Numbers GTC01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Geneticure, LLC
Study Sponsor Geneticure, LLC
Collaborators Not Provided
Investigators
Study Director: Krista Kleve RCRI
PRS Account Geneticure, LLC
Verification Date March 2017