HypertensionPhase 2PGEN for HTNNCT02988245
Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension
A Phase 2 study testing Geneticure Panel for HTN therapy and JNC-8 in people with Hypertension, run by Geneticure, LLC at 15 sites in United States.
Trial summary
Hypertension is one of the most important preventable contributors to disease and death in the United States and represents the most common condition seen in the primary care setting. Approximately 78 million adults living in the U.S. have hypertension with more than 5 million new diagnoses made each year. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Geneticure Panel for HTN therapy and JNC-8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2022to Dec 2023
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with new diagnosis of hypertension or uncontrolled hypertension and on one medication
- Subject is able and willing to provide informed consent
- Subject is ≥ 30 and ≤ 80 years of age
- Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 50
Who cannot join
- Subject has been diagnosed with chronic kidney disease as determined by serum creatinine levels of >1.3 mg/dl for men and >1.1 for women.
- Subject has clinically significant cardiac disease as determined by diagnosed coronary artery disease, diagnosed heart failure, and congenital cardiac disease.
- Subject has clinically significant vascular disease as determined by diagnosed peripheral vascular disease and diagnosed pulmonary hypertension.
- Liver dysfunction is defined using the normal reference range for lower limit of normal and upper limit of normal used by Fairview labs and as determined by diagnosed liver disease /cirrhosis as listed in the patient's problem list based on ICD-10.
- Subject has secondary hypertension.
- Subject has prior diagnosis of endocrine disorders except uncomplicated type 2 diabetes and well controlled hypothyroidism.
Show all 10Show fewer
- Subject is pregnant.
- Subject is breastfeeding.
- Subject becomes pregnant during study
- Subjects lacking the capacity to consent
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Fairview Health Clinics - Andover
Andover, Minnesota, 55304
Fairview Health Clinics - Blaine
Blaine, Minnesota, 55449
Fairview Health Clinics - Bloomington, Oxboro
Bloomington, Minnesota, 55420
Fairview Clinics - Brooklyn Park
Brooklyn Park, Minnesota, 55443
Fairview Clinics- Burnsville
Burnsville, Minnesota, 55337
Fairview Clinics - Columbia Heights
Columbia Heights, Minnesota, 55421
Fairview Health Clinics - Edina
Edina, Minnesota, 55345
Fairview Health Clinics - Elk River
Elk River, Minnesota, 55330
Fairview Clinics - Fridley
Fridley, Minnesota, 55432
Fairview Clinics - Lino Lakes
Lino Lakes, Minnesota, 55014
Fairview Clinics - Hiawatha
Minneapolis, Minnesota, 55406
Fairview Clinic - New Brighton
New Brighton, Minnesota, 55112
Fairview Clinics - North Branch
North Branch, Minnesota, 55056
Fairview Clinics - Wyoming
Wyoming, Minnesota, 55092
Fairview Health Services - Zimmerman
Zimmerman, Minnesota, 55398
About this study
Official title: Prospective Randomized Controlled Trial Investigating the Use of Genetic Predisposition to Guide Pharmacologic Therapy for Hypertension
Hypertension is one of the most important preventable contributors to disease and death in the United States and represents the most common condition seen in the primary care setting. Approximately 78 million adults living in the U.S. have hypertension with more than 5 million new diagnoses made each year. Unfortunately, despite a significant impulse in the medical community to move towards an "individualized medicine" approach to patient centered treatment, the current clinical treatment strategy is based on a set algorithm which does not take into account individual patient differences. As a result hypertension is often sub-optimally treated based on "population averages", rather than a person's genetic make-up, with significant burden on our health care system. In fact, 40% of patients who are adherent to their blood pressure therapy (taking their medicines as prescribed by their clinician) do not have their blood pressure under control. Previous work has demonstrated significant functional polymorphisms within the kidney, vessels, and heart that will likely predict a patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a retrospective design, has determined that the addition of genetic knowledge to prescribing can improve therapeutic guidance and decrease the time to blood pressure control significantly. Despite this, to date, there are no prospective trials to guide blood pressure therapy using multiple organ systems that are important in the three most common classes of drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension in newly diagnosed patients.
Read the detailed description
Specific Aim:
To determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension, when compared to conventional standard of care (JNC 8 guideline directed therapy).
Hypothesis A: Patients randomized to genetically guided blood pressure therapy will have significantly reduced time to optimal blood pressure control compared to conventional standard of care.
Hypotheses B: Patients randomized to genetically guided blood pressure therapy will have significantly greater absolute blood pressure reduction compared to conventional standard of care.
Hypothesis C: Patients randomized to genetically guided blood pressure therapy will have to take fewer classes of blood pressure medicines in order to achieve blood pressure control.
Secondary Aim:
To determine if genetically guided blood pressure therapy reduces number of medication changes in patients with hypertension.
Hypotheses: Patients randomized to genetically guided blood pressure therapy will have significantly less medication changes.
- Conditions
- Hypertension
- Being tested
- Geneticure Panel for HTN therapy, JNC-8
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geneticure Panel for HTN therapyDrug
Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension
JNC-8Drug
Using JNC-8 guidelines to guide therapy
| Study group | Role | What they receive |
|---|---|---|
| Genetically-Guided Treatment for HTN | Experimental | Using a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis. Receives: Drug: Geneticure Panel for HTN therapy |
| JNC-8-Guided Treatment | Active comparator | Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis. Receives: Drug: JNC-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Blood Pressure Control
Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing
Measured: 1 year
Change in Blood Pressure
Change (absolute) in BP (systolic, SBP, diastolic, DBP, and mean arterial, MAP) between genetically-guided prescribing and JNC-8 guided prescribing
Measured: 1 year
Number of Blood Pressure Medicines
Number of blood pressure medicines needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
Measured: 1 year
Secondary outcomes (1)
Number of Medication Changes
Number of blood pressure medicine changes needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startJun 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geneticure, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fairview Health Services, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Pamela Phelps, PharmD, Principal investigator, Fairview Health ServicesWeihong Tang, MD, PhD, Study director, University of MinnesotaMichael Schulenberg, MD, Principal investigator, Fairview Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988245
- Sponsor's protocol ID
- Geneticure
- Acronym
- PGEN for HTN
- Status last verified
- Feb 2022
- First submitted
- 7 Dec 2016
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Investigating the Use of Genetic Predisposition to Guide Pharmacologic Therapy for Hypertension
- ClinicalTrials.gov ID
- NCT02988245
- Acronym / sponsor ID
- PGEN for HTN / Geneticure
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Geneticure, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Fairview Health Services, University of Minnesota
- Study start
- Jun 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Dec 2016 (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.
Hypertension is one of the most important preventable contributors to disease and death in the United States and represents the most common condition seen in the primary care setting. Approximately 78 million adults living in the U.S. have hypertension with more than 5 million new diagnoses made each year. Unfortunately, despite a significant impulse in the medical community to move towards an "individualized medicine" approach to patient centered treatment, the current clinical treatment strategy is based on a set algorithm which does not take into account individual patient differences. As a result hypertension is often sub-optimally treated based on "population averages", rather than a person's genetic make-up, with significant burden on our health care system. In fact, 40% of patients who are adherent to their blood pressure therapy (taking their medicines as prescribed by their clinician) do not have their blood pressure under control. Previous work has demonstrated significant functional polymorphisms within the kidney, vessels, and heart that will likely predict a patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a retrospective design, has determined that the addition of genetic knowledge to prescribing can improve therapeutic guidance and decrease the time to blood pressure control significantly. Despite this, to date, there are no prospective trials to guide blood pressure therapy using multiple organ systems that are important in the three most common classes of drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension in newly diagnosed patients.
Detailed description
Specific Aim:
To determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension, when compared to conventional standard of care (JNC 8 guideline directed therapy).
Hypothesis A: Patients randomized to genetically guided blood pressure therapy will have significantly reduced time to optimal blood pressure control compared to conventional standard of care.
Hypotheses B: Patients randomized to genetically guided blood pressure therapy will have significantly greater absolute blood pressure reduction compared to conventional standard of care.
Hypothesis C: Patients randomized to genetically guided blood pressure therapy will have to take fewer classes of blood pressure medicines in order to achieve blood pressure control.
Secondary Aim:
To determine if genetically guided blood pressure therapy reduces number of medication changes in patients with hypertension.
Hypotheses: Patients randomized to genetically guided blood pressure therapy will have significantly less medication changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetically-Guided Treatment for HTN | Experimental | Drug: Geneticure Panel for HTN therapyUsing a patient's genetic composition to guide BP prescribing for patients with hypertension, post diagnosis. |
| JNC-8-Guided Treatment | Active comparator | Drug: JNC-8Using traditional (JNC-8) guidelines for BP prescribing for patients with hypertension, post diagnosis. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject with new diagnosis of hypertension or uncontrolled hypertension and on one medication
- Subject is able and willing to provide informed consent
- Subject is ≥ 30 and ≤ 80 years of age
- Subject with a Body Mass Index (BMI) ≥ 19 and ≤ 50
Key exclusion criteria (10 listed)
- Subject has been diagnosed with chronic kidney disease as determined by serum creatinine levels of >1.3 mg/dl for men and >1.1 for women.
- Subject has clinically significant cardiac disease as determined by diagnosed coronary artery disease, diagnosed heart failure, and congenital cardiac disease.
- Subject has clinically significant vascular disease as determined by diagnosed peripheral vascular disease and diagnosed pulmonary hypertension.
- Liver dysfunction is defined using the normal reference range for lower limit of normal and upper limit of normal used by Fairview labs and as determined by diagnosed liver disease /cirrhosis as listed in the patient's problem list based on ICD-10.
- Subject has secondary hypertension.
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 Panel for HTN therapyUsing either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension | Drug | Genetically-Guided Treatment for HTN |
| JNC-8Using JNC-8 guidelines to guide therapy | Drug | JNC-8-Guided Treatment |
Primary outcome
Time to Blood Pressure Control
Time frame: 1 year
Time to BP control between genetically-guided prescribing and JNC-8 guided prescribing
Change in Blood Pressure
Time frame: 1 year
Change (absolute) in BP (systolic, SBP, diastolic, DBP, and mean arterial, MAP) between genetically-guided prescribing and JNC-8 guided prescribing
Number of Blood Pressure Medicines
Time frame: 1 year
Number of blood pressure medicines needed to obtain control of hypertension between genetically-guided prescribing and JNC-8 guided prescribing
1 secondary outcome
Number of Medication Changes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Sponsor SiteLink provided by the sponsor.
- 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.
Pamela Phelps, PharmD principal investigator
Fairview Health Services
Weihong Tang, MD, PhD study director
University of Minnesota
Michael Schulenberg, MD principal investigator
Fairview Health Services
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Geneticure Panel for HTN therapy and JNC-8 in people with Hypertension, run by Geneticure, LLC at 15 sites in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric M Snyder, PhD (18003628109 ext. 702, eric@geneticure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Blood Pressure Control (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2022.