Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
Primary Purpose
Supine Hypertension, Autonomic Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tilt
Elevated trunk
Tilt - In home
Elevated Trunk - In home
Sponsored by
About this trial
This is an interventional treatment trial for Supine Hypertension
Eligibility Criteria
Inclusion Criteria:
- Patients with autonomic failure and with supine hypertension from all races
- Males and females, between 18 to 85 years
Exclusion Criteria:
- All medical students
- Pregnant women
- High-risk patients (for example: heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)
- History of serious allergies or asthma.
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Elevation of the whole bed (tilt)
Elevation of the trunk
Elevation of the whole bed (tilt) - In home
Elevation of the trunk - In home
Arm Description
Tilt of the whole bed so that the participant's head is raised by 9 and/or 12 inches.
Elevation of the trunk by tilting just the head of the bed so that the participant's head is raised by 9 and/or 12 inches.
Tilt of the whole bed so that the participant's head is raised by 8 inches.
Elevation of the trunk by raising the head 8 inches on a wedge pillow.
Outcomes
Primary Outcome Measures
Systolic Blood Pressure
Maximal change from baseline in systolic blood pressure during the night
Systolic Blood Pressure
Difference in systolic blood pressure between tilt and elevated trunk sessions
Secondary Outcome Measures
Overnight Urine Volume
Comparison of total urinary volume overnight.
Full Information
NCT ID
NCT04502225
First Posted
July 20, 2020
Last Updated
March 17, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04502225
Brief Title
Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
Official Title
Impact of Decreased Venous Return on Supine Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Many persons with autonomic failure often have high blood pressure when lying down (supine hypertension). This study is exploring the impact of decreased venous return to the heart (achieved by raising the head of the bed) to lessen supine blood pressure. If decreased venous return to the heart is effective at lowering supine blood pressure, these approaches may be utilized to treat supine hypertension non-pharmacologically. Raising the head of the bed decreases the amount of blood returning to the heart due to the effects of gravity. In this case, the decreased blood return to the heart may decrease blood pressure.
Detailed Description
Autonomic failure (AF) is a severely disabling condition, which is characterized by orthostatic hypotension (severe drop in blood pressure upon standing), bladder and bowel dysfunction, and sexual dysfunction. Besides disabling orthostatic hypotension, however, half of these patients have supine hypertension (high blood pressure when lying). Sustained high blood pressure is a cardiac risk for heart disease, kidney disease, and stroke. Sustained supine hypertension during the night induces pressure natriuresis (increased urine production due to high blood pressure) and volume loss (due to frequent urination/high volumes of urine), worsening orthostatic hypotension the following morning (blood pressure falls even more when the blood volume has been decreased due to loss of fluids in urine) and may also complicate the treatment of orthostatic hypotension with pressor agents (giving a blood pressure pill to prevent overnight high blood pressure may make daytime standing blood pressure worse).
Upright posture induces significant gravitational pooling of blood in the lower body that is normally compensated for by sympathetic activation. Failure of compensatory sympathetic activation results in orthostatic hypotension in autonomic failure patients due to the reduction in venous return and cardiac output. This abnormality has been used in autonomic failure patients with supine hypertension to their benefit by having them sleep with the head of the bed tilted up. The recommended amount of head up tilt is 10°, or about a 9-inch elevation of the head of the bed. In the investigators' hands this degree of tilt produces a significant but only modest decrease in blood pressure. Compliance is a limiting factor because most patients (and their spouses) are not able to tolerate even this modest level of head up tilt. Participants often elevate just the torso overnight, but the effect of this approach on supine blood pressure has not been reported.The investigators would like to compare the effects of tilt versus only elevating the head on supine blood pressure.
The existing knowledge provides the rationale for the study of the elevation of the head of the bed as a non-pharmacologic approaches for the treatment of supine hypertension in these patients. Elevation of the head of the bed will decrease venous return to the heart using the effects of gravity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supine Hypertension, Autonomic Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized comparison of the effects of two amounts of head elevation (9 and 12 inches) achieved by tilting the bed or raising the head of the bed (up to four comparisons made) on supine blood pressure
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elevation of the whole bed (tilt)
Arm Type
Experimental
Arm Description
Tilt of the whole bed so that the participant's head is raised by 9 and/or 12 inches.
Arm Title
Elevation of the trunk
Arm Type
Experimental
Arm Description
Elevation of the trunk by tilting just the head of the bed so that the participant's head is raised by 9 and/or 12 inches.
Arm Title
Elevation of the whole bed (tilt) - In home
Arm Type
Experimental
Arm Description
Tilt of the whole bed so that the participant's head is raised by 8 inches.
Arm Title
Elevation of the trunk - In home
Arm Type
Experimental
Arm Description
Elevation of the trunk by raising the head 8 inches on a wedge pillow.
Intervention Type
Other
Intervention Name(s)
Tilt
Intervention Description
Tilt of the whole bed so that the head is elevated by 9 and/or 12 inches in an acute trial or overnight.
Intervention Type
Other
Intervention Name(s)
Elevated trunk
Intervention Description
Elevation of the trunk through raising just the head of the bed until the head is elevated by 9 and/or 12 inches in an acute trial or overnight.
Intervention Type
Other
Intervention Name(s)
Tilt - In home
Intervention Description
Tilt of the whole bed so that the head is elevated by 8 inches overnight.
Intervention Type
Other
Intervention Name(s)
Elevated Trunk - In home
Intervention Description
Elevation of the trunk through raising the head 8 inches on a wedge pillow overnight.
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Maximal change from baseline in systolic blood pressure during the night
Time Frame
10 PM to 8 AM
Title
Systolic Blood Pressure
Description
Difference in systolic blood pressure between tilt and elevated trunk sessions
Time Frame
10 PM to 8 AM or acute session (1 hour at each elevation of the head)
Secondary Outcome Measure Information:
Title
Overnight Urine Volume
Description
Comparison of total urinary volume overnight.
Time Frame
10 PM to 8 AM
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with autonomic failure and with supine hypertension from all races
Males and females, between 18 to 85 years
Exclusion Criteria:
All medical students
Pregnant women
High-risk patients (for example: heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)
History of serious allergies or asthma.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily C Smith, RN BSN MPH
Phone
6158751516
Email
emily.c.smith@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily C Smith, RN BSN MPH
Phone
6158751516
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
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