HypertensionNCT02524873
Relationship Between Genes Important in Blood Pressure Regulation and Blood Pressure Therapy in Hypertension
An observational study of Hypertension, run by Geneticure, LLC.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Geneticure Collection Kit for Pharmaocogenetics of Hypertension
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypertension
Who may be able to join
- 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.
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- Diuretics
- ACE Inhibitors
- Angiotensin Receptor Blocker (ARB)
- Beta-blockers
Who cannot join
- Subject has clinically significant kidney disease as determined by the investigator.
- Subject has clinically significant cardiac disease as determined by the investigator.
- Subject has clinically significant vascular disease as determined by the investigator.
- Subject has a diagnosis of secondary hypertension or is experiencing a complication of pregnancy.
- 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.
- Subject has Systolic BP > 190 or Diastolic BP > 120 documented within the six months prior to visit.
Show all 10Show fewer
- Subject has a regular alcohol intake of greater than 21 units per week in the past 6 months
- Subject has smoked greater than two packs of cigarettes (total) or equivalent nicotine intake in the past 6 months.
- Subject has an anticipated survival less than 12 months.
- Any other reason that the subject is inappropriate for study enrollment in the opinion of the Investigator.
About this study
Official title: 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
Read the 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.
- Conditions
- Hypertension
- Being tested
- Geneticure Collection Kit for Pharmaocogenetics of Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geneticure Collection Kit for Pharmaocogenetics of HypertensionDevice
Buccal (cheek) swab kit for DNA collection for analysis of genes for hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (2)
The clinical time to achieve optimal blood pressure treatment
Measured: One year
The number of office visits required to achieve optimal blood pressure treatment.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geneticure, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krista Kleve, Study director, RCRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524873
- Sponsor's protocol ID
- GTC01
- Status last verified
- Mar 2017
- First submitted
- 10 Aug 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between Genes That Encode Proteins Important in Blood Pressure Regulation and Blood Pressure Therapy in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT02524873
- Acronym / sponsor ID
- GTC01
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Geneticure, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypertension
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- Subject has clinically significant kidney disease as determined by the investigator.
- Subject has clinically significant cardiac disease as determined by the investigator.
- Subject has clinically significant vascular disease as determined by the investigator.
- Subject has a diagnosis of secondary hypertension or is experiencing a complication of pregnancy.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geneticure Collection Kit for Pharmaocogenetics of HypertensionBuccal (cheek) swab kit for DNA collection for analysis of genes for hypertension | Device | – |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Results publicationJohnson 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
- Results publicationJohnson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista Kleve study director
RCRI
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Geneticure, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory blood pressure changes (using sphygmomanometry) in response to therapy according to genes important in blood pressure regulation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524873, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.