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Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03312556
Enrollment
12
Registered
2017-10-17
Start date
2017-09-21
Completion date
2026-12-21
Last updated
2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Failure, Supine Hypertension

Keywords

hypertension, supine hypertension, autonomic failure, pure autonomic failure, multiple system atrophy, cpap

Brief 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. 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.

Interventions

DEVICEcontinuous positive airway pressure (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.

DRUGPlacebo

Placebo pill or patch. Single dose

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients with autonomic failure and with supine hypertension from all races

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Supine Systolic Blood Pressure12 hourschange in supine systolic blood pressure from baseline

Secondary

MeasureTime frameDescription
Urinary volume12 hoursNocturnal urinary volume

Countries

United States

Contacts

Primary ContactBonnie K Black, RN
autonomics@vumc.org615-343-6862
Backup ContactLuis E Okamoto, MD
autonomics@vumc.org(615) 936-6119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026