Management of Uncontrolled Hypertension (HTN)

Study Overview
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Brief Summary
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In this study, investigators will compare chronotherapy to ABPM. Data collected will include hypertension drug therapy regimen prior to and during the study, timing of medication administration, and dose, along with the patient's office blood pressure values prior to study and one month after modification in therapy. This will enable us to explore whether it is a practical endeavor to implement ABPM as a routine process for all uncontrolled hypertension patients or whether ABPM does not seem to provide considerable value over shifting the timing of drug administration.

Detailed Description
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Investigators propose to conduct a pilot study to determine whether the incorporation of Ambulatory Blood Pressure Monitoring (ABPM) as routine procedure in clinic for uncontrolled hypertension influences how anti-hypertensive drug therapy is modified or if simply shifting the dosing of anti-hypertensive medications to night time achieves similar results. Investigators will enroll 20 participants with uncontrolled hypertension, who are prescribed 3 anti-hypertensive medications at maximum dose. All twenty patients will undergo 24-hour blood pressure monitoring with ABPM at baseline and one month after change in therapy has been initiated; ten of the patients will be randomized to receive a shift in dosing schedule of anti-hypertensive medication to night-time without utilizing their ABPM results while the remaining ten will receive modifications in therapy based on their ABPM results and dipping status. The results of this study will assist in assessing the feasibility and benefits of the incorporation of ABPM into the routine management of hypertension.

Official Title
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Management of Uncontrolled Hypertension: Ambulatory Blood Pressure Monitoring and Subsequent Modification of Therapy or Shifting Anti-hypertensive Medication to Night-time Dosing

Conditions
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Hypertension

Intervention / Treatment
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* Device: Ambulatory blood pressure monitor (ABPM)
* Other: Chronotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age ≥ 18 years Blood pressure of >130/80 mmHg Currently receiving 3 anti-hypertensive agents, one of which is a diuretic, for at least six weeks Exclusion criteria 1. Vulnerable populations Pregnant women Prisoners Cognitively impaired persons Economically and/or educationally disadvantaged Human fetuses and neonates Patients who work night-shift Children Conditions with visual field deterioration (Anterior Ischemic Optic Neuropathy, Glaucoma, Optic Nerve Disorders)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chronotherapy<br>Chronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results. | Other: Chronotherapy<br>* Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.<br>|
| Active Comparator: ABPM<br>ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen. | Device: Ambulatory blood pressure monitor (ABPM)<br>* ABPM allows providers to obtain blood pressure readings over a 24 hour period, to assess blood pressure at night to determine dipping status, and to evaluate the efficacy of anti-hypertensive therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Blood Pressure | changes in blood pressure from baseline vs after 1 month of change in drug therapy for each patient. Measured by T-test | Changes between Baseline and 1 month | 
| Amount of Subjects From Each Group That Achieved Blood Pressure Goal | Measured using Chi-square test or Fisher's Exact Test | 1 month |