Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure

Autonomic Failure Clinical Trial

Official title:

Impact of Decreased Venous Return on Supine Blood Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04502225
• Other study ID #: 200124
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Bonnie K Black, RN
• Phone: 615-343-6862
• Email: bonnie.black[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Failure
• Pure Autonomic Failure
• Supine Hypertension

Intervention

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.
• 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.
• Tilt - In home
Tilt of the whole bed so that the head is elevated by 8 inches overnight.
• Elevated Trunk - In home
Elevation of the trunk through raising the head 8 inches on a wedge pillow overnight.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Maximal change from baseline in systolic blood pressure during the night	10 PM to 8 AM
Primary	Systolic Blood Pressure	Difference in systolic blood pressure between tilt and elevated trunk sessions	10 PM to 8 AM or acute session (1 hour at each elevation of the head)
Secondary	Overnight Urine Volume	Comparison of total urinary volume overnight.	10 PM to 8 AM