Supine HypertensionNCT03312556
Treatment of Supine Hypertension in Autonomic Failure (CPAP)
A study testing continuous positive airway pressure (CPAP) in people with Supine Hypertension and Autonomic Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. 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?
- continuous positive airway pressure (CPAP)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 21 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who cannot join
- All medical students
- Pregnant women
- High-risk patients (e.g. 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
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Emily C Smith, RN, 615-875-1516, autonomics@vumc.org
Bonnie K Black, RN, 615-343-6862, autonomics@vumc.org
About this study
Official title: Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure
Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.
Read the detailed description
Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined.
This study will test the hypothesis that continuous positive airway pressure (CPAP) has an acute lowering-BP effect in autonomic failure patients with supine hypertension. CPAP is a widely-used treatment for sleep-related breathing disorders including sleep apnea, that uses mild air pressure to keep the breathing airways open. It involves using a CPAP machine that blows air into a tube connected to a mask placed over the nose, or nose and mouth. For these studies, a commercial CPAP device will be used to apply pressure sequentially at 0, 4, 8, 12 and 16 cm H2O for 1-20 minute each. Depending on the BP response and tolerability to CPAP, CPAP may be applied during the night using a CPAP level that was tolerable and showed a BP-lowering effect during the acute test.
- Conditions
- Supine Hypertension, Autonomic Failure
- Being tested
- continuous positive airway pressure (CPAP), Placebo
- Keywords
- hypertension, supine hypertension, autonomic failure, pure autonomic failure, multiple system atrophy, cpap
- Medical subject headings
- Pure Autonomic Failure, Hypertension, Multiple System Atrophy, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure (CPAP)Device
Also called CPAP
Continuous positive airway pressure(CPAP) will be applied during the night starting from 20:00. CPAP level will be determined during an acute CPAP trial.
PlaceboDrug
Also called placebo pill or patch
Placebo pill or patch. Single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo pill or patch or sham CPAP | Placebo comparator | Placebo pill or patch or sham CPAP Receives: Drug: Placebo |
| CPAP (continuous positive airway pressure) | Active comparator | Continuous positive airway pressure during the night Receives: Device: continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supine Systolic Blood Pressure
change in supine systolic blood pressure from baseline
Measured: 12 hours
Secondary outcomes (1)
Urinary volume
Nocturnal urinary volume
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start21 Sep 2017
- Primary completion21 Sep 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03312556
- Sponsor's protocol ID
- 010189-1
- Other IDs
- 200124
- Status last verified
- Nov 2025
- First submitted
- 12 Oct 2017
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Okamoto LE, Celedonio JE, Smith EC, Paranjape SY, Black BK, Wahba A, Park JW, Shibao CA, Diedrich A, Biaggioni I. Continuous Positive Airway Pressure for the Treatment of Supine Hypertension and Orthostatic Hypotension in Autonomic Failure. Hypertension. 2023 Mar;80(3):650-658. doi: 10.1161/HYPERTENSIONAHA.122.20081. Epub 2023 Jan 5.
PubMed 36601916
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT03312556
- Acronym / sponsor ID
- 010189-1
- Conditions
- Supine Hypertension, Autonomic Failure
- Keywords
- hypertension, supine hypertension, autonomic failure, pure autonomic failure, multiple system atrophy, cpap
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.
Detailed description
Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined.
This study will test the hypothesis that continuous positive airway pressure (CPAP) has an acute lowering-BP effect in autonomic failure patients with supine hypertension. CPAP is a widely-used treatment for sleep-related breathing disorders including sleep apnea, that uses mild air pressure to keep the breathing airways open. It involves using a CPAP machine that blows air into a tube connected to a mask placed over the nose, or nose and mouth. For these studies, a commercial CPAP device will be used to apply pressure sequentially at 0, 4, 8, 12 and 16 cm H2O for 1-20 minute each. Depending on the BP response and tolerability to CPAP, CPAP may be applied during the night using a CPAP level that was tolerable and showed a BP-lowering effect during the acute test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo pill or patch or sham CPAP | Placebo comparator | Drug: PlaceboPlacebo pill or patch or sham CPAP |
| CPAP (continuous positive airway pressure) | Active comparator | Device: continuous positive airway pressure (CPAP)Continuous positive airway pressure during the night |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with autonomic failure and with supine hypertension from all races
Key exclusion criteria (4 listed)
- All medical students
- Pregnant women
- High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)
- History of serious allergies or asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous positive airway pressure (CPAP)Also: CPAPContinuous positive airway pressure(CPAP) will be applied during the night starting from 20:00. CPAP level will be determined during an acute CPAP trial. | Device | CPAP (continuous positive airway pressure) |
| PlaceboAlso: placebo pill or patchPlacebo pill or patch. Single dose | Drug | Placebo pill or patch or sham CPAP |
Primary outcome
Supine Systolic Blood Pressure
Time frame: 12 hours
change in supine systolic blood pressure from baseline
1 secondary outcome
Urinary volume
Time frame: 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Derived from this study: PubMed 36601916Okamoto LE, Celedonio JE, Smith EC, Paranjape SY, Black BK, Wahba A, Park JW, Shibao CA, Diedrich A, Biaggioni I. Continuous Positive Airway Pressure for the Treatment of Supine Hypertension and Orthostatic Hypotension in Autonomic Failure. Hypertension. 2023 Mar;80(3):650-658. doi: 10.1161/HYPERTENSIONAHA.122.20081. Epub 2023 Jan 5.
- Individual participant dataSharing planned: No
Related trials for Supine Hypertension
Recruiting
Effect of Raised Head of the Bed on Lying Blood Pressure in Autonomic Failure
Supine Hypertension, Autonomic Failure
Enrolling by invitationPhase 2
Droxidopa / Pyridostigmine in Orthostatic Hypotension
Orthostatic Hypotension
Recruiting
CPAP for the Treatment of Supine Hypertension
Autonomic Failure, Pure Autonomic Failure
Active, not recruitingPhase 1
Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic
Multiple System Atrophy, Orthostatic Hypotension
Recruiting
Overnight Trials With Heat Stress in Autonomic Failure Patients With Supine Hypertension
Hypertension, Pure Autonomic Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Italo Biaggioni, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure (CPAP) in people with Supine Hypertension and Autonomic Failure, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bonnie K Black, RN (615-343-6862, autonomics@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supine Systolic Blood Pressure (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.