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NCT Number: NCT04502225

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Emily C Smith, RN BSN MPH

CONTACT

CONTACT

6158751516

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tilt

Other

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

Other

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

Other

Tilt of the whole bed so that the head is elevated by 8 inches overnight.

Elevated Trunk - In home

Other

Elevation of the trunk through raising the head 8 inches on a wedge pillow overnight.

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 10 PM to 8 AM

    Maximal change from baseline in systolic blood pressure during the night

  2. Systolic Blood Pressure

    Time frame: 10 PM to 8 AM or acute session (1 hour at each elevation of the head)

    Difference in systolic blood pressure between tilt and elevated trunk sessions

Secondary outcomes

  1. Overnight Urine Volume

    Time frame: 10 PM to 8 AM

    Comparison of total urinary volume overnight.

Study contacts

Contact information is provided by the study sponsor or research team.

Bonnie K Black, RN

CONTACT

[email protected]

615-343-6862

Luis E. Okamoto, MD

CONTACT

[email protected]

(615) 936-6119

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Impact of Decreased Venous Return on Supine Blood Pressure

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2020
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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