Supine HypertensionNCT04502225
Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
A study testing Tilt, Elevated trunk and Tilt - In home in people with Supine Hypertension and Autonomic Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Supine Hypertension, Autonomic Failure
- What is being tested?
- Tilt, Elevated trunk and Tilt - In home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2020to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with autonomic failure and with supine hypertension from all races
- Males and females, between 18 to 85 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Emily C Smith, RN BSN MPH
6158751516
About this study
Official title: 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.
Read the 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.
- Conditions
- Supine Hypertension, Autonomic Failure
- Being tested
- Tilt, Elevated trunk, Tilt - In home, Elevated Trunk - In home
- Medical subject headings
- Pure Autonomic Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiltOther
Tilt of the whole bed so that the head is elevated by 9 and/or 12 inches in an acute trial or overnight.
Elevated trunkOther
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 homeOther
Tilt of the whole bed so that the head is elevated by 8 inches overnight.
Elevated Trunk - In homeOther
Elevation of the trunk through raising the head 8 inches on a wedge pillow overnight.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Elevated Trunk - In home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Maximal change from baseline in systolic blood pressure during the night
Measured: 10 PM to 8 AM
Systolic Blood Pressure
Difference in systolic blood pressure between tilt and elevated trunk sessions
Measured: 10 PM to 8 AM or acute session (1 hour at each elevation of the head)
Secondary outcomes (1)
Overnight Urine Volume
Comparison of total urinary volume overnight.
Measured: 10 PM to 8 AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start21 Aug 2020
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supine HypertensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Italo Biaggioni, Vanderbilt University Medical Center
- Investigators
- Italo Biaggioni, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502225
- Sponsor's protocol ID
- 200124
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No