Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT04502225

Conditions

Supine Hypertension

Autonomic Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tilt

Elevated trunk

Tilt - In home

Elevated Trunk - In home

Study Details

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

Study ID

NCT04502225

Start date

Aug 21, 2020

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

experimental: Elevation of the trunk - In home

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

Interventions

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.

Primary outcome measure

  • Systolic Blood Pressure [ Time Frame: 10 PM to 8 AM ]
  • Systolic Blood Pressure [ Time Frame: 10 PM to 8 AM or acute session (1 hour at each elevation of the head) ]

Central Contacts and Locations

Central contacts

Bonnie K Black, RN

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

Luis E. Okamoto, MD

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

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

6158751516

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-11-06.