HypertensionNCT02121041
Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
A study testing Amlodipine, Chlorthalidone and Losartan in people with Hypertension, run by Anthony J Viera, MD, MPH at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine, Chlorthalidone and Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2016
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 30 years and ≤ 65 years
- Most recent (within 14 days) clinic systolic BP 126-150 mm Hg
- Able/willing to wear a BP monitor for 24 hours on multiple occasions
- Able/willing to take daily anti-hypertensive medication if indicated
- Able to read and speak English
Who cannot join
- Pregnant or trying to become pregnant
- Known heart disease
- History of persistent atrial fibrillation
- Currently taking antihypertensive medication
- Currently taking Simvastatin > 20mg daily
- Clinician recommends against participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.
Read the detailed description
The usual strategy for detecting hypertension-repeated office blood pressure (BP) measurements-is inefficient and inaccurate. When paired with ambulatory BP monitoring (ABPM), which takes a multitude of measurements over 24 hours, it is clear that office BP measurements may convey a falsely positive diagnosis known as white-coat hypertension. What is less well-known is that office BP measurements may also convey a falsely negative diagnosis termed masked hypertension (MH). That is, office BP may measure as normal, yet 24-hour ambulatory measurements show elevated BP. People with MH have cardiovascular risk that is similar to that of people with diagnosed hypertension, yet MH goes unrecognized, and therefore, untreated. Ultimately, identifying the best strategy for accurately detecting hypertension is vital to improving overall BP control and reducing cardiovascular events. Without a feasible ABPM strategy, MH will continue to go unrecognized and untreated.
Participants enrolled in the study will be randomized to either the usual care group or the ABPM-guided group. All participants will have a baseline ABPM. ABPM will be used to make a diagnosis and determine anti-hypertensive treatment in the ABPM-guided group only. Participants in the ABPM-guided group will have a follow-up ABPM in 2 months. All participants will have a final ABPM 4 months after enrollment.
- Conditions
- Hypertension
- Being tested
- Amlodipine, Chlorthalidone, Losartan
- Keywords
- Hypertension, Blood Pressure, Ambulatory Blood Pressure Monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Also called Norvasc
Amlodipine 5 mg or 10 mg
ChlorthalidoneDrug
Also called Thalitone
Chlorthalidone 12.5 mg or 25 mg
LosartanDrug
Also called Cozaar
Losartan 50 mg or 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care. |
| ABPM Guided | Active comparator | Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan. Receives: Drug: Amlodipine; Drug: Chlorthalidone; Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Blood Pressure Average at the End of 4 Month Participation.
Measured: Participants will be on study average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionJul 2016
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthony J Viera, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor-investigator, Anthony J Viera, MD, MPH, University of North Carolina, Chapel Hill
- Investigators
- Anthony J Viera, MD, MPH, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121041
- Sponsor's protocol ID
- 14-0670
- Status last verified
- Dec 2016
- First submitted
- 16 Apr 2014
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
- ClinicalTrials.gov ID
- NCT02121041
- Acronym / sponsor ID
- 14-0670
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood Pressure, Ambulatory Blood Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Anthony J Viera, MD, MPHUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Posted 19 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.
Detailed description
The usual strategy for detecting hypertension-repeated office blood pressure (BP) measurements-is inefficient and inaccurate. When paired with ambulatory BP monitoring (ABPM), which takes a multitude of measurements over 24 hours, it is clear that office BP measurements may convey a falsely positive diagnosis known as white-coat hypertension. What is less well-known is that office BP measurements may also convey a falsely negative diagnosis termed masked hypertension (MH). That is, office BP may measure as normal, yet 24-hour ambulatory measurements show elevated BP. People with MH have cardiovascular risk that is similar to that of people with diagnosed hypertension, yet MH goes unrecognized, and therefore, untreated. Ultimately, identifying the best strategy for accurately detecting hypertension is vital to improving overall BP control and reducing cardiovascular events. Without a feasible ABPM strategy, MH will continue to go unrecognized and untreated.
Participants enrolled in the study will be randomized to either the usual care group or the ABPM-guided group. All participants will have a baseline ABPM. ABPM will be used to make a diagnosis and determine anti-hypertensive treatment in the ABPM-guided group only. Participants in the ABPM-guided group will have a follow-up ABPM in 2 months. All participants will have a final ABPM 4 months after enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care. |
| ABPM Guided | Active comparator | Drug: Amlodipine, Drug: Chlorthalidone, Drug: LosartanParticipants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 30 years and ≤ 65 years
- Most recent (within 14 days) clinic systolic BP 126-150 mm Hg
- Able/willing to wear a BP monitor for 24 hours on multiple occasions
- Able/willing to take daily anti-hypertensive medication if indicated
- Able to read and speak English
Key exclusion criteria (6 listed)
- Pregnant or trying to become pregnant
- Known heart disease
- History of persistent atrial fibrillation
- Currently taking antihypertensive medication
- Currently taking Simvastatin > 20mg daily
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 |
|---|---|---|
| AmlodipineAlso: NorvascAmlodipine 5 mg or 10 mg | Drug | ABPM Guided |
| ChlorthalidoneAlso: ThalitoneChlorthalidone 12.5 mg or 25 mg | Drug | ABPM Guided |
| LosartanAlso: CozaarLosartan 50 mg or 100 mg | Drug | ABPM Guided |
Primary outcome
24 Hour Blood Pressure Average at the End of 4 Month Participation.
Time frame: Participants will be on study average of 4 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- 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.
Anthony J Viera, MD, MPH principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amlodipine, Chlorthalidone and Losartan in people with Hypertension, run by Anthony J Viera, MD, MPH 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 10 Feb 2017. 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 19 Dec 2016). 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?
24 Hour Blood Pressure Average at the End of 4 Month Participation. (time frame: Participants will be on study average of 4 months.). 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 10 Feb 2017.