Management of Uncontrolled Hypertension (HTN)

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02922023
• Other study ID #: IRB201601421
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 25, 2021

Study information

• Verified date: November 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion criteria

1. Age = 18 years

2. Blood pressure of >130/80 mmHg

3. Currently receiving 3 anti-hypertensive agents, one of which is a diuretic, for at least six weeks

Exclusion criteria

1. Vulnerable populations

1. Pregnant women

2. Prisoners

3. Cognitively impaired persons

4. Economically and/or educationally disadvantaged

5. Human fetuses and neonates

6. Patients who work night-shift

7. Children

8. Conditions with visual field deterioration (Anterior Ischemic Optic Neuropathy, Glaucoma, Optic Nerve Disorders)

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Amount of Subjects From Each Group That Achieved Blood Pressure Goal	Measured using Chi-square test or Fisher's Exact Test	1 month