OPTImizing Precision of Hypertension Care to Maximize Blood Pressure Control Pilot (OPTI-BP Pilot)

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.

Conditions

• High Blood Pressure

Interventions

OTHER

HTN PRA 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.

OTHER

Blood Sample

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.

Sponsors & Collaborators

• OneFlorida Clinical Research Consortium

  collaborator OTHER

• University of Florida

  lead OTHER

Principal Investigators

• Rhonda M Cooper-DeHoff, PharmD, MS · University of Florida

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-18

Primary Completion

2018-06-30

Completion

2018-06-30

Countries

• United States

Study Locations