Clinical trial NCT02814552: OPTImizing Precision of Hypertension Care to Maximize Blood Pressure Control Pilot (OPTI-BP Pilot)
Official title: OPTImizing Precision of Hypertension Care to Maximize Blood Pressure Control Pilot (OPTI-BP Pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: OneFlorida Clinical Research Consortium
First posted: 2016-06-27
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: BP control
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Macclenny
country: United States
facility: UF Health Family Medicine
state: Florida
city: Old Town
country: United States
facility: UF Health Family Medicine - Old Town
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Rhonda M Cooper-DeHoff, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.