OPTImizing Precision of Hypertension Care to Maximize Blood Pressure Control Pilot (OPTI-BP Pilot)
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/27/2018 |
| Start Date: | June 18, 2016 |
| End Date: | June 30, 2018 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
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