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

NCT ID: NCT04502225

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-21

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Supine Hypertension Autonomic Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tilt

Intervention Type OTHER

Tilt of the whole bed so that the head is elevated by 9 and/or 12 inches in an acute trial or overnight.

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.

Group Type EXPERIMENTAL

Elevated trunk

Intervention Type 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.

Elevation of the whole bed (tilt) - In home

Tilt of the whole bed so that the participant's head is raised by 8 inches.

Group Type EXPERIMENTAL

Tilt - In home

Intervention Type OTHER

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

Elevation of the trunk - In home

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

Group Type EXPERIMENTAL

Elevated Trunk - In home

Intervention Type OTHER

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

Interventions

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Tilt

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

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.

Intervention Type OTHER

Tilt - In home

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

Intervention Type OTHER

Elevated Trunk - In home

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Italo Biaggioni

Professor of Medicine and Pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Italo Biaggioni, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bonnie K Black, RN

Role: CONTACT

Phone: 615-343-6862

Email: [email protected]

Luis E. Okamoto, MD

Role: CONTACT

Phone: (615) 936-6119

Email: [email protected]

Facility Contacts

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Emily C Smith, RN BSN MPH

Role: primary

Role: backup

Other Identifiers

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200124

Identifier Type: -

Identifier Source: org_study_id