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Management of Uncontrolled Hypertension (HTN)

Primary Purpose

Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambulatory blood pressure monitor (ABPM)
Chronotherapy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Blood pressure of >140/90 mmHg for patients less than 60 years or >150/90 for patients 60 years or older
  • Currently receiving 3 anti-hypertensive agents, one of which is a diuretic, for at least 6 weeks

Exclusion Criteria:

  • Pregnant women
  • Prisoners
  • Cognitively impaired persons
  • Minorities
  • Economically and/or educationally disadvantaged
  • Human fetuses and neonates
  • Children
  • Conditions with visual field deterioration (Anterior Ischemic Optic Neuropathy, Glaucoma, Optic Nerve Disorders)

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chronotherapy

ABPM

Arm Description

Chronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results.

ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen.

Outcomes

Primary Outcome Measures

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
Amount of Subjects From Each Group That Achieved Blood Pressure Goal
Measured using Chi-square test or Fisher's Exact Test

Secondary Outcome Measures

Full Information

First Posted
September 30, 2016
Last Updated
November 18, 2022
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02922023
Brief Title
Management of Uncontrolled Hypertension (HTN)
Official Title
Management of Uncontrolled Hypertension: Ambulatory Blood Pressure Monitoring and Subsequent Modification of Therapy or Shifting Anti-hypertensive Medication to Night-time Dosing
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Subjects lost to follow-up
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronotherapy
Arm Type
Active Comparator
Arm Description
Chronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results.
Arm Title
ABPM
Arm Type
Active Comparator
Arm Description
ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen.
Intervention Type
Device
Intervention Name(s)
Ambulatory blood pressure monitor (ABPM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chronotherapy
Intervention Description
Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.
Primary Outcome Measure Information:
Title
Changes in Blood Pressure
Description
changes in blood pressure from baseline vs after 1 month of change in drug therapy for each patient. Measured by T-test
Time Frame
Changes between Baseline and 1 month
Title
Amount of Subjects From Each Group That Achieved Blood Pressure Goal
Description
Measured using Chi-square test or Fisher's Exact Test
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Vogel Anderson, Pharm D
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Management of Uncontrolled Hypertension (HTN)

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