Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with autonomic failure and with supine hypertension from all races
Males and females, between 18 to 85 years
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Tilt
Other interventionTilt 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 interventionElevation 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 interventionTilt of the whole bed so that the head is elevated by 8 inches overnight.
Elevated Trunk - In home
Other interventionElevation of the trunk through raising the head 8 inches on a wedge pillow overnight.
Treatment groups
44 Participants
are divided into 4 treatment groupsGroup A: Elevation of the whole bed (tilt)Experimental treatment 1 intervention
Group B: Elevation of the trunkExperimental treatment 1 intervention
Group C: Elevation of the whole bed (tilt) - In homeExperimental treatment 1 intervention
Group D: Elevation of the trunk - In homeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Systolic Blood Pressure
Maximal change from baseline in systolic blood pressure during the night
Time frame
10 PM to 8 AM2
Systolic Blood Pressure
Difference in systolic blood pressure between tilt and elevated trunk sessions
Time frame
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.
Time frame
10 PM to 8 AMSponsors and contacts
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Source ClinicalTrials.gov