Treatment of Masked Hypertension
Primary Purpose
Masked Hypertension, Hypertension, Chronic Renal Insufficiency
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Antihypertensive medication intensification
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Masked Hypertension
Eligibility Criteria
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Antihypertensive medication intensification
Usual care
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from baseline in urine albumin to creatinine ratio at 4 months
Change from baseline in pulse wave velocity at 4 months
Change from baseline in 24hr ambulatory systolic blood pressure at 4 months
Full Information
NCT ID
NCT02142881
First Posted
May 16, 2014
Last Updated
December 27, 2017
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT02142881
Brief Title
Treatment of Masked Hypertension
Official Title
Treatment of Masked Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 7, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Masked Hypertension, Hypertension, Chronic Renal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antihypertensive medication intensification
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Antihypertensive medication intensification
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Antihypertensive medications will be adjusted by the participants' providers (usual care).
Primary Outcome Measure Information:
Title
Percentage of participants with masked hypertension
Description
Percentage of participants with masked hypertension defined as a 24hr ambulatory systolic blood pressure >130 mmHg and a clinic systolic blood pressure <140 mmHg
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change from baseline in urine albumin to creatinine ratio at 4 months
Time Frame
Baseline, 4 months
Title
Change from baseline in pulse wave velocity at 4 months
Time Frame
Baseline, 4 months
Title
Change from baseline in 24hr ambulatory systolic blood pressure at 4 months
Time Frame
Baseline, 4 months
Other Pre-specified Outcome Measures:
Title
Percentage of participants with masked hypertension
Description
Percentage of participants with masked hypertension defined as a 24hr ambulatory systolic blood pressure >130 mmHg and a clinic systolic blood pressure <140 mmHg
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Drawz, MD, MHS, MS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Masked Hypertension
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