Hypertension
Conditions
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.
Interventions
DEVICEAmbulatory 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.
OTHERChronotherapy
Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Pressure | 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 |
| Amount of Subjects From Each Group That Achieved Blood Pressure Goal | 1 month | Measured using Chi-square test or Fisher's Exact Test |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronotherapy Chronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results.
Chronotherapy: Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results. | 2 |
| ABPM ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen.
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. | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Chronotherapy | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Age, Continuous | 71.5 years STANDARD_DEVIATION 5.5 | 71.5 years STANDARD_DEVIATION 5.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 0 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Amount of Subjects From Each Group That Achieved Blood Pressure Goal
Measured using Chi-square test or Fisher's Exact Test
Time frame: 1 month
Population: Data were not collected for either subject as they both withdrew from the study.
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
Time frame: Changes between Baseline and 1 month
Population: Data were not collected for either subject as they both withdrew from the study.