What side effects are associated with this type of intervention?

Raising the head of the bed to decrease venous return to the heart is a non-pharmacological approach to managing supine hypertension. This method primarily aims to reduce blood pressure by leveraging gravity to limit blood flow back to the heart. Known side effects are minimal and generally include potential discomfort or difficulty sleeping in an inclined position. Unlike pharmacological treatments, this approach does not typically involve systemic side effects such as dizziness, fatigue, or electrolyte imbalances.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned for the treatment of supine hypertension in the provided context. The trial discussed focuses on a non-pharmacological approach, specifically raising the head of the bed to decrease venous return to the heart and manage supine hypertension. This method leverages gravity to reduce blood pressure without the use of medication.

What other types of research exist?

Promising alternatives to raising the head of the bed for treating supine hypertension include: 1) Continuous Positive Airway Pressure (CPAP) therapy, which has been shown to improve pulmonary hemodynamics and reduce blood pressure increments during sleep. 2) Oral appliances, such as mandibular advancement devices, which can be effective in managing obstructive sleep apnea and related cardiovascular effects. These alternatives offer non-pharmacological options that can be discussed with a healthcare provider.

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Raised Head of Bed for Autonomic Failure

N/A

Recruiting

Led By Italo Biaggioni, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 pm to 8 am

Awards & highlights

Summary

This trial is testing if lifting the head of the bed can help lower high blood pressure in patients with autonomic failure. These patients often have high blood pressure when lying down, which can worsen their condition. By raising the head of the bed, gravity helps keep some blood in the lower body, reducing the amount that returns to the heart and potentially lowering blood pressure.

Who is the study for?

This trial is for adults aged 18-85 with autonomic failure who experience high blood pressure when lying down. It's open to all races and genders. Medical students, pregnant women, those at high risk (like heart failure or stroke), or with serious allergies/asthma cannot participate.

What is being tested?

The study tests if raising the head of the bed can lower blood pressure in patients with autonomic failure by reducing the amount of blood returning to the heart due to gravity. This non-drug approach could be a new way to treat supine hypertension.

What are the potential side effects?

Since this intervention involves physical adjustments rather than medication, side effects may include discomfort from sleeping at an incline or potential muscle strain but are expected to be minimal compared to drug therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 pm to 8 am or acute session (1 hour at each elevation of the head)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 pm to 8 am or acute session (1 hour at each elevation of the head)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 pm to 8 am or acute session (1 hour at each elevation of the head) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Systolic Blood Pressure

Secondary study objectives

Overnight Urine Volume

Trial Design

4Treatment groups

Experimental Treatment

Group I: Elevation of the whole bed (tilt) - In homeExperimental Treatment1 Intervention

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

Group II: Elevation of the whole bed (tilt)Experimental Treatment1 Intervention

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

Group III: Elevation of the trunk - In homeExperimental Treatment1 Intervention

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

Group IV: Elevation of the trunkExperimental Treatment1 Intervention

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary mechanism of action for treating supine hypertension by raising the head of the bed involves decreasing venous return to the heart. This is achieved through the effects of gravity, which reduces the amount of blood returning to the heart when the patient is lying down. By lowering venous return, the overall blood pressure is reduced, which is particularly beneficial for patients with supine hypertension as it helps to manage high blood pressure without the need for pharmacological interventions. This method is significant because it offers a non-invasive, simple, and effective way to control blood pressure, potentially reducing the risk of complications associated with high blood pressure during sleep.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

888 Previous Clinical Trials

934,890 Total Patients Enrolled

2 Trials studying Supine Hypertension

71 Patients Enrolled for Supine Hypertension

Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University Medical Center

Vanderbilt University Medical Center

28 Previous Clinical Trials

1,410 Total Patients Enrolled

2 Trials studying Supine Hypertension

71 Patients Enrolled for Supine Hypertension

Media Library

Raised Head of the Bed Clinical Trial Eligibility Overview. Trial Name: NCT04502225 — N/A

Supine Hypertension Research Study Groups: Elevation of the trunk - In home, Elevation of the trunk, Elevation of the whole bed (tilt) - In home, Elevation of the whole bed (tilt)

Supine Hypertension Clinical Trial 2023: Raised Head of the Bed Highlights & Side Effects. Trial Name: NCT04502225 — N/A

Raised Head of the Bed 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502225 — N/A

~9 spots leftby Sep 2025

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