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
|Condition or disease||Intervention/treatment|
|Hypertension||Device: Geneticure Collection Kit for Pharmaocogenetics of Hypertension|
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|
|Actual Enrollment :||99 participants|
|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|
- Device: Geneticure Collection Kit for Pharmaocogenetics of Hypertension
Buccal (cheek) swab kit for DNA collection for analysis of genes for hypertension
- 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.
- 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 ]
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
|Study Director:||Krista Kleve||RCRI|