Masked HypertensionPhase 3NCT02142881
Treatment of Masked Hypertension
A Phase 3 study testing Antihypertensive medication intensification in people with Masked Hypertension and Hypertension, run by University of Minnesota at 1 site in United States.
Trial summary
To date, most observational and all intervention studies have defined hypertension on the basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Masked Hypertension, Hypertension, Chronic Renal Insufficiency
- What is being tested?
- Antihypertensive medication intensification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 7 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- 30 < eGFR < 70 ml/min/1.73m2 within 9 months of the screening visit
- Urine albumin to creatinine ratio >100mg/gm OR a urinalysis with ≥30mg/dL albuminuria within 9 months of the screening visit
- Most recent clinic systolic BP >120 and <140 mmHg within 9 months of the screening visit
- Masked hypertension at the screening and baseline visits
- Clinic systolic BP <140 mmHg
Show all 9Show fewer
- 24hr ambulatory systolic BP > 130 mmHg
- Taking ≤ 2 antihypertensive medications
- No change in antihypertensive medications for the past 6 months
Who cannot join
- Heart failure
- Lightheaded with standing
- Loss of consciousness in the past 24 months
- Non-English speakers
- History of breast cancer requiring a mastectomy or radiation on the side of the non-dominant arm and unable or refuses to use the dominant arm for ambulatory BP monitoring
- Cardiovascular event or procedure or hospitalization for unstable angina within the last 3 months
- Inability to perform ambulatory BP monitoring due to compliance or other clinical reason
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
To date, most observational and all intervention studies have defined hypertension on the basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause mortality. Using clinic and ambulatory BPs, patients can be categorized as normotensive (normal clinic and ambulatory BPs), white-coat hypertension (elevated clinic BP with normal ambulatory BP), masked hypertension (normal clinic BP with elevated ambulatory BP), and sustained hypertension (elevated clinic and ambulatory BP). Approximately one third of patients with chronic kidney disease (CKD) with normal clinic BP have elevated ambulatory BP (masked hypertension). We demonstrated that, among participants from the Chronic Renal Insufficiency Cohort (CRIC) study, low estimated glomerular filtration rate (eGFR) and elevated proteinuria are associated with increased odds of masked hypertension. Additionally, participants with masked hypertension had increased risk for target organ damage as assessed by left ventricular mass and pulse wave velocity. These results in participants with CKD are consistent with prior studies in patients with normal renal function that demonstrated a two-fold increased risk for cardiovascular events in patients with masked hypertension compared to patients with normal clinic and ambulatory BP. Despite this elevated risk for adverse outcomes, patients with masked hypertension have been excluded from hypertension trials because of their normal clinic BP. Therefore, it is unknown whether the reduction in target organ damage and adverse cardiovascular outcomes associated with treatment of hypertension extends to patients with masked hypertension. To address this important gap in knowledge, we are planning a randomized, controlled trial to evaluate whether antihypertensive treatment can modify BP patterns in patients with masked hypertension, that is, convert them to controlled clinic and ambulatory BP. We will also evaluate the effect antihypertensive treatment on target organ damage in patients with masked hypertension. The current study is a pilot randomized controlled trial to evaluate the feasibility of the planned trial and the effect of antihypertensive therapy on clinic and ambulatory BP, proteinuria, and target organ damage in patients with masked hypertension.
- Being tested
- Antihypertensive medication intensification, Usual care
- Medical subject headings
- Masked Hypertension, Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive medication intensificationOther
Antihypertensive medications will be adjusted by study staff based on ambulatory and clinic BP results at baseline and 2 months with a target 24hr systolic blood pressure of <130 mmHg.
Usual careOther
Antihypertensive medications will be adjusted by the participants' providers (usual care).
| Study group | Role | What they receive |
|---|---|---|
| Antihypertensive medication intensification | Experimental | Not described Receives: Other: Antihypertensive medication intensification |
| Usual care | Other | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with masked hypertension
Percentage of participants with masked hypertension defined as a 24hr ambulatory systolic blood pressure >130 mmHg and a clinic systolic blood pressure <140 mmHg
Measured: 4 months
Secondary outcomes (3)
Change from baseline in urine albumin to creatinine ratio at 4 months
Measured: Baseline, 4 months
Change from baseline in pulse wave velocity at 4 months
Measured: Baseline, 4 months
Change from baseline in 24hr ambulatory systolic blood pressure at 4 months
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJun 2014
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Masked HypertensionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul E Drawz, MD, MHS, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142881
- Sponsor's protocol ID
- 1404M49925
- Status last verified
- Dec 2017
- First submitted
- 16 May 2014
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Masked Hypertension
- ClinicalTrials.gov ID
- NCT02142881
- Acronym / sponsor ID
- 1404M49925
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date, most observational and all intervention studies have defined hypertension on the basis of clinic blood pressure (BP). Measurement of BP outside the clinic with home or ambulatory BP provides a better estimate of the risk of cardiovascular disease and all-cause mortality. Using clinic and ambulatory BPs, patients can be categorized as normotensive (normal clinic and ambulatory BPs), white-coat hypertension (elevated clinic BP with normal ambulatory BP), masked hypertension (normal clinic BP with elevated ambulatory BP), and sustained hypertension (elevated clinic and ambulatory BP). Approximately one third of patients with chronic kidney disease (CKD) with normal clinic BP have elevated ambulatory BP (masked hypertension). We demonstrated that, among participants from the Chronic Renal Insufficiency Cohort (CRIC) study, low estimated glomerular filtration rate (eGFR) and elevated proteinuria are associated with increased odds of masked hypertension. Additionally, participants with masked hypertension had increased risk for target organ damage as assessed by left ventricular mass and pulse wave velocity. These results in participants with CKD are consistent with prior studies in patients with normal renal function that demonstrated a two-fold increased risk for cardiovascular events in patients with masked hypertension compared to patients with normal clinic and ambulatory BP. Despite this elevated risk for adverse outcomes, patients with masked hypertension have been excluded from hypertension trials because of their normal clinic BP. Therefore, it is unknown whether the reduction in target organ damage and adverse cardiovascular outcomes associated with treatment of hypertension extends to patients with masked hypertension. To address this important gap in knowledge, we are planning a randomized, controlled trial to evaluate whether antihypertensive treatment can modify BP patterns in patients with masked hypertension, that is, convert them to controlled clinic and ambulatory BP. We will also evaluate the effect antihypertensive treatment on target organ damage in patients with masked hypertension. The current study is a pilot randomized controlled trial to evaluate the feasibility of the planned trial and the effect of antihypertensive therapy on clinic and ambulatory BP, proteinuria, and target organ damage in patients with masked hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antihypertensive medication intensification | Experimental | Other: Antihypertensive medication intensification |
| Usual care | Other | Other: Usual care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years
- 30 < eGFR < 70 ml/min/1.73m2 within 9 months of the screening visit
- Urine albumin to creatinine ratio >100mg/gm OR a urinalysis with ≥30mg/dL albuminuria within 9 months of the screening visit
- Most recent clinic systolic BP >120 and <140 mmHg within 9 months of the screening visit
- Masked hypertension at the screening and baseline visits
Key exclusion criteria (7 listed)
- Heart failure
- Lightheaded with standing
- Loss of consciousness in the past 24 months
- Non-English speakers
- History of breast cancer requiring a mastectomy or radiation on the side of the non-dominant arm and unable or refuses to use the dominant arm for ambulatory BP monitoring
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 |
|---|---|---|
| Antihypertensive medication intensificationAntihypertensive medications will be adjusted by study staff based on ambulatory and clinic BP results at baseline and 2 months with a target 24hr systolic blood pressure of <130 mmHg. | Other | Antihypertensive medication intensification |
| Usual careAntihypertensive medications will be adjusted by the participants' providers (usual care). | Other | Usual care |
Primary outcome
Percentage of participants with masked hypertension
Time frame: 4 months
Percentage of participants with masked hypertension defined as a 24hr ambulatory systolic blood pressure >130 mmHg and a clinic systolic blood pressure <140 mmHg
3 secondary outcomes
Change from baseline in urine albumin to creatinine ratio at 4 months
Time frame: Baseline, 4 months
Change from baseline in pulse wave velocity at 4 months
Time frame: Baseline, 4 months
Change from baseline in 24hr ambulatory systolic blood pressure at 4 months
Time frame: Baseline, 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
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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.
Paul E Drawz, MD, MHS, MS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antihypertensive medication intensification in people with Masked Hypertension and Hypertension, run by University of Minnesota 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 9 inclusion and 7 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 29 Dec 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants with masked hypertension (time frame: 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 29 Dec 2017.