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

October 24, 2018 updated by: University of Florida
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Macclenny, Florida, United States, 32063
        • UF Health Family Medicine
      • Old Town, Florida, United States, 32680
        • UF Health Family Medicine - Old Town
      • Tallahassee, Florida, United States, 32307
        • Tallahassee Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: High Blood Pressure Consented
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.
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 Names:
  • on-line app
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.
No Intervention: De-identified historical data
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
OneFlorida Clinical Research Consortium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201501060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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