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Management of Uncontrolled Hypertension (HTN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02922023
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : January 7, 2020
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Ambulatory blood pressure monitor (ABPM) Other: Chronotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Uncontrolled Hypertension: Ambulatory Blood Pressure Monitoring and Subsequent Modification of Therapy or Shifting Anti-hypertensive Medication to Night-time Dosing
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Chronotherapy
Chronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results.
Other: Chronotherapy
Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.

Active Comparator: ABPM
ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen.
Device: Ambulatory blood pressure monitor (ABPM)
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.

Primary Outcome Measures :
  1. Changes in blood pressure [ Time Frame: Changes between Baseline and 1 month ]
    changes in blood pressure from baseline vs after 1 month of change in drug therapy for each patient. Measured by T-test

  2. Amount of subjects from each group that achieved blood pressure goal [ Time Frame: 1 month ]
    Measured using Chi-square test or Fisher's Exact Test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02922023

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Contact: Katherine Vogel Anderson, Pharm D 352-273-6240
Contact: Ben Burkley, MS 352-273-5283

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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Kathrine Vogel Anderson, PharmD    352-273-6240   
Sponsors and Collaborators
University of Florida
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Principal Investigator: Katherine Vogel Anderson, Pharm D University of Florida

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Responsible Party: University of Florida Identifier: NCT02922023    
Other Study ID Numbers: IRB201601421
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents