Management of Uncontrolled Hypertension (HTN)

NCT02922023 | Terminated Results FDA Device

• 1 other identifier: IRB201601421
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Chronotherapy

ACTIVE COMPARATOR

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

Other: Chronotherapy

ABPM

ACTIVE COMPARATOR

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

Device: Ambulatory blood pressure monitor (ABPM)

Interventions

Ambulatory blood pressure monitor (ABPM) DEVICE

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.

ABPM

Chronotherapy OTHER

Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.

Chronotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Chronotherapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Katherine Vogel Anderson, Pharm.D., BCACP, FCCP
• Organization: University of Florida Colleges of Pharmacy and Medicine

kvanderson@cop.ufl.edu

352-273-6240

Study Officials

• Katherine Vogel Anderson, Pharm D

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 3, 2016
• Study Start: January 1, 2017
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)