Treatment of Masked Hypertension

December 27, 2017 updated by: University of Minnesota
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 24hr ambulatory systolic BP > 130 mmHg
  • Taking ≤ 2 antihypertensive medications
  • No change in antihypertensive medications for the past 6 months

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Usual care
Other: Usual care
Antihypertensive medications will be adjusted by the participants' providers (usual care).
Experimental: Antihypertensive medication intensification
Other: Antihypertensive medication intensification
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in urine albumin to creatinine ratio at 4 months
Time Frame: Baseline, 4 months
Baseline, 4 months
Change from baseline in pulse wave velocity at 4 months
Time Frame: Baseline, 4 months
Baseline, 4 months
Change from baseline in 24hr ambulatory systolic blood pressure at 4 months
Time Frame: Baseline, 4 months
Baseline, 4 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with masked hypertension
Time Frame: 2 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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul E Drawz, MD, MHS, MS, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1404M49925

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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