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Subjects lost to follow-up
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| ABPM | Active Comparator | ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
Exclusion criteria
1. Vulnerable populations
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Vogel Anderson, Pharm D | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Data were not collected for either subject as they both withdrew from the study. | Posted | Changes between Baseline and 1 month |
|
2 years
2 subjects were enrolled; however, they did not complete the study so no adverse events occured
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Vogel Anderson, Pharm.D., BCACP, FCCP | University of Florida Colleges of Pharmacy and Medicine | 352-273-6240 | kvanderson@cop.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2022 | Oct 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019454 | Chronotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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. |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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.
|
| Primary | Amount of Subjects From Each Group That Achieved Blood Pressure Goal | Measured using Chi-square test or Fisher's Exact Test | Data were not collected for either subject as they both withdrew from the study. | Posted | 1 month |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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