High Blood Pressure Clinical Trial
Official title:
OPTImizing Precision of Hypertension Care to Maximize Blood Pressure Control Pilot (OPTI-BP Pilot)
Verified date | October 2018 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UF Health Family Medicine | Macclenny | Florida |
United States | UF Health Family Medicine - Old Town | Old Town | Florida |
United States | Tallahassee Memorial Hospital | Tallahassee | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | OneFlorida Clinical Research Consortium |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03812614 -
Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
|
N/A | |
Completed |
NCT03650166 -
High BP and Home Monitoring Experience (HoME) Study
|
N/A | |
Recruiting |
NCT02908139 -
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
|
N/A | |
Completed |
NCT01622400 -
Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk
|
N/A | |
Completed |
NCT00659672 -
Effect of Whey Protein on Blood Pressure
|
N/A | |
Completed |
NCT00473681 -
Intervention Study to Control High Blood Pressure for Korean American
|
N/A | |
Completed |
NCT03542240 -
Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome
|
N/A | |
Active, not recruiting |
NCT05526092 -
OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals
|
N/A | |
Completed |
NCT02218931 -
ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes
|
N/A | |
Recruiting |
NCT03753204 -
Salt-Sensitivity and Immunity Cell Activation
|
Phase 1/Phase 2 | |
Completed |
NCT04479384 -
The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study.
|
N/A | |
Not yet recruiting |
NCT04064281 -
The Healthy Cantonese Diet on Cardiometabolic Syndrome
|
N/A | |
Completed |
NCT04082819 -
MediBeat - HeartBeat Observation Trial
|
N/A | |
Completed |
NCT03555344 -
Effect of Mantra on Hypertensive Patients
|
N/A | |
Withdrawn |
NCT03319823 -
Treating Nocturnal Hypertension and Nocturia in African American Men
|
Phase 4 | |
Completed |
NCT00689819 -
Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients
|
N/A | |
Completed |
NCT00417170 -
Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome
|
Phase 2 | |
Completed |
NCT00130156 -
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
|
Phase 4 | |
Completed |
NCT05808556 -
Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure
|
N/A | |
Recruiting |
NCT05321368 -
A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities
|
N/A |