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.|
|ClinicalTrials.gov Identifier: NCT02922023|
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Device: Ambulatory blood pressure monitor (ABPM) Other: Chronotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02922023
|Contact: Katherine Vogel Anderson, Pharm Dfirstname.lastname@example.org|
|Contact: Ben Burkley, MSemail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Kathrine Vogel Anderson, PharmD 352-273-6240 firstname.lastname@example.org|
|Principal Investigator:||Katherine Vogel Anderson, Pharm D||University of Florida|