High Blood PressureNCT02814552
OPTImizing Precision of Hypertension Care to Maximize Blood Pressure Control Pilot (OPTI-BP Pilot)
A study testing HTN PRA App and Blood Sample in people with High Blood Pressure, run by University of Florida at 3 sites in United States.
Trial summary
Hypertension (HTN) is a major risk factor for coronary heart disease (CHD), heart failure, kidney failure and stroke. Disparities in HTN prevalence, treatment and control in the US have persisted for decades. The prevalence of HTN is 44% among Blacks, which is among the highest rates in the world. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- HTN PRA App and Blood Sample
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jun 2016to 30 Jun 2018
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- untreated HTN (systolic BP ≥ 140 or diastolic BP ≥ 90 mm Hg while taking no anti-HTN drugs)
- treated, uncontrolled HTN (systolic BP ≥ 140 or diastolic BP ≥ 90 mm Hg while taking one or more anti-HTN drug)
- provide voluntary, written informed consent
- willing to comply with requirements of the study including provision of a blood sample for local laboratory determined PRA.
Who cannot join
- treated and controlled HTN (systolic BP < 140 mm Hg and diastolic BP < 90 mm Hg)
- systolic BP ≥ 180 mm Hg or diastolic BP ≥ 110 mm Hg
- secondary forms of HTN or any active, unstable disease process requiring new diagnostic and therapeutic plans
- any life-threatening illness
- history of alcohol or drug abuse in the past 5 years
- mental illness or personality disorder that might interfere with adherence to study protocol
Show all 9Show fewer
- end-stage renal disease and progressive chronic kidney disease with serum creatinine >2.5 mg/dl
- intolerance to two or more classes of anti-HTN medications
- pregnant women or breast feeding women
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UF Health Family Medicine
Macclenny, Florida, 32063
UF Health Family Medicine - Old Town
Old Town, Florida, 32680
Tallahassee Memorial Hospital
Tallahassee, Florida, 32307
About this study
Hypertension (HTN) is a major risk factor for coronary heart disease (CHD), heart failure, kidney failure and stroke. Disparities in HTN prevalence, treatment and control in the US have persisted for decades. The prevalence of HTN is 44% among Blacks, which is among the highest rates in the world. Those in ethnic/racial, rural, socioeconomically disadvantaged and other medically underserved populations are known to have the worst blood pressure (BP) control. Awareness of, treatment for, and control of HTN is not optimal, and varies according to race, whereby BP is controlled in ~53% of non-Latino Whites, 42% of non-Latino Blacks and only 34% of Latinos. Fundamental underlying differences in the pathophysiology contribute to HTN among different race groups. The United States (US) 2014 HTN recommendations outline race-based pharmacotherapy care for HTN. However, these recommendations use race-based population assumptions for Whites and Blacks only, do not include Latino ethnicity and have no accompanying guidelines or tools for successful implementation, particularly in rural primary care practices where disparate populations are common. Moreover, these recommendations only apply to initial therapy and lack guidance on subsequent regimen selection. The Optimizing Precision of HTN Care to Maximize BP Control Pilot (OPTI-BP Pilot), will directly address a long known and growing health disparity concern in the US which includes higher rates of death from CHD and stroke among Blacks and the poorest rates of HTN control among Latinos. Utilizing a mixed methods approach, the overarching goal of OPTI-BP Pilot is to test, using a pragmatic trial design, a personalized, algorithmic-based HTN management approach focused on age, race, biomarker (plasma renin activity) and treatment factors. The investigators hypothesize that implementation of a precision-based approach to the care of HTN in the community will improve BP reduction and ultimately reduce risk for CHD, stroke and death among those most affected by HTN.OPTI-BP Pilot is significant because it will utilize an innovative, systematic, precision-focused HTN management approach in an underserved, diverse population where BP control is currently suboptimal and lays the infrastructure groundwork for broad implementation across all areas of the US to minimize HTN related disparities and improve HTN outcomes.
Read the detailed description
The purpose of this research study is to develop pilot data to support a more precise way to treat high blood pressure based on an individual person's specific characteristics. Information from a blood test called plasma renin activity will be entered into an on-line app that may more precisely determine which medication should be used to treat high blood pressure than random selection. Renin is a substance in the body that is known to affect your blood pressure. By measuring plasma renin activity, and using that to select a blood pressure lowering medication it may help to more precisely select medications based on how an individual will respond.
- Conditions
- High Blood Pressure
- Being tested
- HTN PRA App, Blood Sample
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTN PRA AppOther
Also called on-line app
The HTN PRA App will be used to adjust standard of care medication dosages for high blood pressure drugs which may include: thiazide diuretic (water pill), usually called hydrochlorothiazide (HCTZ) or chlorthalidone, and an ACE inhibitor or an angiotensin receptor blocker.
Blood SampleOther
Blood sample for plasma renin activity activity will be obtained at least once (at baseline) and if BP is not controlled after 1-3 months, an additional blood sample may be obtained.
| Study group | Role | What they receive |
|---|---|---|
| High Blood Pressure Consented | Other | Participants will have the following performed: medical history and blood pressure levels will be collected, and blood samples. Then using the HTN PRA App recommendation regarding standard of care medication dosing will be adjusted for optimal blood pressure control. Receives: Other: HTN PRA App; Other: Blood Sample |
| De-identified historical data | No intervention | De-identified historical data will be collect based on age (no dates), blood pressure of treated (noted with medications), blood pressure of non-treated (noted without medications), and list of medications. The data will be compared to the High Blood Pressure Consented group to determine the effect of using the HTN PRA App. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP control
We will measure BP control in patients who underwent PRA testing. BP control in the PRA tested patients will be compared with historic control patients who did not undergo PRA testing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start18 Jun 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- OneFlorida Clinical Research Consortium
- Responsible party
- Sponsor
- Investigators
- Rhonda M Cooper-DeHoff, PharmD, MS, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814552
- Sponsor's protocol ID
- IRB201501060
- Status last verified
- Oct 2018
- First submitted
- 23 Jun 2016
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mehanna M, Chen YE, Gong Y, Handberg E, Roth B, De Leon J, Smith SM, Harrell JG, Cooper-DeHoff RM. Optimizing Precision of Hypertension Care to Maximize Blood Pressure Control: A Pilot Study Utilizing a Smartphone App to Incorporate Plasma Renin Activity Testing. Clin Transl Sci. 2021 Mar;14(2):617-624. doi: 10.1111/cts.12922. Epub 2020 Nov 30.
PubMed 33142006
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImizing Precision of Hypertension Care to Maximize Blood Pressure Control Pilot (OPTI-BP Pilot)
- ClinicalTrials.gov ID
- NCT02814552
- Acronym / sponsor ID
- IRB201501060
- Conditions
- High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- OneFlorida Clinical Research Consortium
- Study start
- 18 Jun 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 27 Jun 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 (HTN) is a major risk factor for coronary heart disease (CHD), heart failure, kidney failure and stroke. Disparities in HTN prevalence, treatment and control in the US have persisted for decades. The prevalence of HTN is 44% among Blacks, which is among the highest rates in the world. Those in ethnic/racial, rural, socioeconomically disadvantaged and other medically underserved populations are known to have the worst blood pressure (BP) control. Awareness of, treatment for, and control of HTN is not optimal, and varies according to race, whereby BP is controlled in ~53% of non-Latino Whites, 42% of non-Latino Blacks and only 34% of Latinos. Fundamental underlying differences in the pathophysiology contribute to HTN among different race groups. The United States (US) 2014 HTN recommendations outline race-based pharmacotherapy care for HTN. However, these recommendations use race-based population assumptions for Whites and Blacks only, do not include Latino ethnicity and have no accompanying guidelines or tools for successful implementation, particularly in rural primary care practices where disparate populations are common. Moreover, these recommendations only apply to initial therapy and lack guidance on subsequent regimen selection. The Optimizing Precision of HTN Care to Maximize BP Control Pilot (OPTI-BP Pilot), will directly address a long known and growing health disparity concern in the US which includes higher rates of death from CHD and stroke among Blacks and the poorest rates of HTN control among Latinos. Utilizing a mixed methods approach, the overarching goal of OPTI-BP Pilot is to test, using a pragmatic trial design, a personalized, algorithmic-based HTN management approach focused on age, race, biomarker (plasma renin activity) and treatment factors. The investigators hypothesize that implementation of a precision-based approach to the care of HTN in the community will improve BP reduction and ultimately reduce risk for CHD, stroke and death among those most affected by HTN.OPTI-BP Pilot is significant because it will utilize an innovative, systematic, precision-focused HTN management approach in an underserved, diverse population where BP control is currently suboptimal and lays the infrastructure groundwork for broad implementation across all areas of the US to minimize HTN related disparities and improve HTN outcomes.
Detailed description
The purpose of this research study is to develop pilot data to support a more precise way to treat high blood pressure based on an individual person's specific characteristics. Information from a blood test called plasma renin activity will be entered into an on-line app that may more precisely determine which medication should be used to treat high blood pressure than random selection. Renin is a substance in the body that is known to affect your blood pressure. By measuring plasma renin activity, and using that to select a blood pressure lowering medication it may help to more precisely select medications based on how an individual will respond.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Blood Pressure Consented | Other | Other: HTN PRA App, Other: Blood SampleParticipants will have the following performed: medical history and blood pressure levels will be collected, and blood samples. Then using the HTN PRA App recommendation regarding standard of care medication dosing will be adjusted for optimal blood pressure control. |
| De-identified historical data | No intervention | –De-identified historical data will be collect based on age (no dates), blood pressure of treated (noted with medications), blood pressure of non-treated (noted without medications), and list of medications. The data will be compared to the High Blood Pressure Consented group to determine the effect of using the HTN PRA App. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- untreated HTN (systolic BP ≥ 140 or diastolic BP ≥ 90 mm Hg while taking no anti-HTN drugs)
- treated, uncontrolled HTN (systolic BP ≥ 140 or diastolic BP ≥ 90 mm Hg while taking one or more anti-HTN drug)
- provide voluntary, written informed consent
- willing to comply with requirements of the study including provision of a blood sample for local laboratory determined PRA.
Key exclusion criteria (9 listed)
- treated and controlled HTN (systolic BP < 140 mm Hg and diastolic BP < 90 mm Hg)
- systolic BP ≥ 180 mm Hg or diastolic BP ≥ 110 mm Hg
- secondary forms of HTN or any active, unstable disease process requiring new diagnostic and therapeutic plans
- any life-threatening illness
- history of alcohol or drug abuse in the past 5 years
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 |
|---|---|---|
| HTN PRA AppAlso: on-line appThe HTN PRA App will be used to adjust standard of care medication dosages for high blood pressure drugs which may include: thiazide diuretic (water pill), usually called hydrochlorothiazide (HCTZ) or chlorthalidone, and an ACE inhibitor or an angiotensin receptor blocker. | Other | High Blood Pressure Consented |
| Blood SampleBlood sample for plasma renin activity activity will be obtained at least once (at baseline) and if BP is not controlled after 1-3 months, an additional blood sample may be obtained. | Other | High Blood Pressure Consented |
Primary outcome
BP control
Time frame: 6 months
We will measure BP control in patients who underwent PRA testing. BP control in the PRA tested patients will be compared with historic control patients who did not undergo PRA testing.
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 25 Oct 2018.
- Derived from this study: PubMed 33142006Mehanna M, Chen YE, Gong Y, Handberg E, Roth B, De Leon J, Smith SM, Harrell JG, Cooper-DeHoff RM. Optimizing Precision of Hypertension Care to Maximize Blood Pressure Control: A Pilot Study Utilizing a Smartphone App to Incorporate Plasma Renin Activity Testing. Clin Transl Sci. 2021 Mar;14(2):617-624. doi: 10.1111/cts.12922. Epub 2020 Nov 30.
- Individual participant dataSharing planned: Undecided
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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.
Rhonda M Cooper-DeHoff, PharmD, MS principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTN PRA App and Blood Sample in people with High Blood Pressure, run by University of Florida at 3 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 9 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
BP control (time frame: 6 months). 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 NCT02814552, which also lists 1 linked publication.
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 25 Oct 2018.