HypertensionNCT02922023
Management of Uncontrolled Hypertension (HTN)
A study testing Ambulatory blood pressure monitor (ABPM) and Chronotherapy in people with Hypertension, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Ambulatory blood pressure monitor (ABPM) and Chronotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 25 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Vulnerable populations
- Pregnant women
- Prisoners
- Cognitively impaired persons
- Economically and/or educationally disadvantaged
- Human fetuses and neonates
Show all 9Show fewer
- Patients who work night-shift
- Children
- Conditions with visual field deterioration (Anterior Ischemic Optic Neuropathy, Glaucoma, Optic Nerve Disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Uncontrolled Hypertension: Ambulatory Blood Pressure Monitoring and Subsequent Modification of Therapy or Shifting Anti-hypertensive Medication to Night-time Dosing
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Ambulatory blood pressure monitor (ABPM), Chronotherapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ChronotherapyOther
Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chronotherapy |
| ABPM | Active comparator | ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen. Receives: Device: Ambulatory blood pressure monitor (ABPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startJan 2017
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Why it stopped: Subjects lost to follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Vogel Anderson, Pharm D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922023
- Sponsor's protocol ID
- IRB201601421
- Status last verified
- Nov 2022
- First submitted
- 30 Sep 2016
- Last updated
- 2 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Uncontrolled Hypertension: Ambulatory Blood Pressure Monitoring and Subsequent Modification of Therapy or Shifting Anti-hypertensive Medication to Night-time Dosing
- ClinicalTrials.gov ID
- NCT02922023
- Acronym / sponsor ID
- IRB201601421
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subjects lost to follow-up
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Posted 2 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronotherapy | Active comparator | Other: ChronotherapyChronotherapy group automatically receives a shift in 1 anti-hypertensive medication to night-time without assessment of ambulatory blood pressure monitor results. |
| ABPM | Active comparator | Device: Ambulatory blood pressure monitor (ABPM)ABPM group will have their ambulatory blood pressure monitor results reviewed prior to deciding to change regimen. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 1. Vulnerable populations
- Pregnant women
- Prisoners
- Cognitively impaired persons
- Economically and/or educationally disadvantaged
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ABPM |
| ChronotherapyChronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results. | Other | Chronotherapy |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Vogel Anderson, Pharm D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory blood pressure monitor (ABPM) and Chronotherapy in people with Hypertension, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood Pressure (time frame: Changes between Baseline and 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.