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

Impact of Decreased Venous Return on Supine Blood Pressure

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.

Study Overview

• Status: Recruiting
• Conditions: Supine Hypertension; Autonomic Failure
• Intervention / Treatment: Other: Tilt; Other: Elevated trunk; Other: Tilt - In home; Other: Elevated Trunk - In home

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bonnie K Black, RN; Phone Number: 615-343-6862; Email: bonnie.black@vumc.org
• Study Contact Backup: Name: Luis E. Okamoto, MD; Phone Number: (615) 936-6119; Email: luis.e.okamoto@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Emily C Smith, RN BSN MPH
      • Contact: Phone Number: 6158751516

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elevation of the whole bed (tilt); Tilt of the whole bed so that the participant's head is raised by 9 and/or 12 inches.	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.
Experimental: Elevation of the trunk; 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.	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.
Experimental: Elevation of the whole bed (tilt) - In home; Tilt of the whole bed so that the participant's head is raised by 8 inches.	Other: Tilt - In home; Tilt of the whole bed so that the head is elevated by 8 inches overnight.
Experimental: Elevation of the trunk - In home; Elevation of the trunk by raising the head 8 inches on a wedge pillow.	Other: Elevated Trunk - In home; Elevation of the trunk through raising the head 8 inches on a wedge pillow overnight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Maximal change from baseline in systolic blood pressure during the night	10 PM to 8 AM
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overnight Urine Volume	Comparison of total urinary volume overnight.	10 PM to 8 AM

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Italo Biaggioni, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Pure Autonomic Failure; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Posture; Nursing Services; Head-Down Tilt; Home Care Services
• Other Study ID Numbers: 200124 (Other Identifier: VUMC IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No