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

Assessment of the Relationship Between Genes That Encode Proteins Important in Blood Pressure Regulation and Blood Pressure Therapy in Patients With Hypertension

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 99

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertension

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulatory blood pressure changes (using sphygmomanometry) in response to therapy according to genes important in blood pressure regulation	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.	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
The clinical time to achieve optimal blood pressure treatment	One year
The number of office visits required to achieve optimal blood pressure treatment.	One year

Collaborators and Investigators

• Sponsor: Geneticure, LLC
• Investigators: Study Director: Krista Kleve, RCRI

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 18, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: GTC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No