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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
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geneticure Collection Kit for Pharmaocogenetics of Hypertension | Device | Buccal (cheek) swab kit for DNA collection for analysis of genes for hypertension |
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Subject is able and willing to provide informed consent
Subject is ≥ 30 and ≤ 70 years of age
Subject with diagnosis of Hypertension for a minimum of 1 year
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.
Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 35
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.
Exclusion Criteria:
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Patients with hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Krista Kleve | RCRI | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 | ||
| Result | 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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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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