Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tilt, Elevated trunk, Tilt - In home, Elevated Trunk - In home.
- Who it may be relevant to
- Registry conditions: Supine Hypertension, Autonomic Failure. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Decreased Venous Return on Supine Blood Pressure
Overview
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.
Interventions
- Other Tilt
Tilt of the whole bed so that the head is elevated by 9 and/or 12 inches in an acute trial or overnight. - Other Elevated trunk
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. - Other Tilt - In home
Tilt of the whole bed so that the head is elevated by 8 inches overnight. - Other Elevated Trunk - In home
Elevation of the trunk through raising the head 8 inches on a wedge pillow overnight.
Primary outcome measures
- Systolic Blood Pressure [Time frame: 10 PM to 8 AM]
- Systolic Blood Pressure [Time frame: 10 PM to 8 AM or acute session (1 hour at each elevation of the head)]
Secondary outcome measures (1)
- Overnight Urine Volume [Time frame: 10 PM to 8 AM]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT04502225 · 200124