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

NCT04502225 | Recruiting

• 1 other identifier: 200124
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Supine Hypertension; Autonomic Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Overnight Urine Volume

  10 PM to 8 AM

Study Arms (4)

Elevation of the whole bed (tilt)

EXPERIMENTAL

Tilt of the whole bed so that the participant's head is raised by 9 and/or 12 inches.

Other: Tilt

Elevation of the trunk

EXPERIMENTAL

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 whole bed (tilt) - In home

EXPERIMENTAL

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

Other: Tilt - In home

Elevation of the trunk - In home

EXPERIMENTAL

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

Other: Elevated Trunk - In home

Interventions

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.

Elevation of the whole bed (tilt)

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.

Elevation of the trunk

Tilt - In home OTHER

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

Elevation of the whole bed (tilt) - In home

Elevated Trunk - In home OTHER

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

Elevation of the trunk - In home

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with autonomic failure and with supine hypertension from all races
• Males and females, between 18 to 85 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Pure Autonomic Failure

Interventions

Head-Down Tilt; Home Care Services

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Nursing Services

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bonnie K Black, RN

CONTACT

615-343-6862; bonnie.black@vumc.org

Luis E. Okamoto, MD

CONTACT

(615) 936-6119; luis.e.okamoto@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Model Details: 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

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: August 6, 2020
• Study Start: August 21, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)