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Treatment of Supine Hypertension in Autonomic Failure (CPAP)
NCT03312556 · Vanderbilt University Medical Center
In plain English
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Official title
Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 12 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2017-09-21
Estimated completion: 2026-12-21
Last updated: 2025-11-06
Interventions
Device: continuous positive airway pressure (CPAP)Drug: Placebo
Primary outcomes
- • Supine Systolic Blood Pressure (12 hours)
Sponsor
Vanderbilt University Medical Center · other
Contacts & investigators
ContactBonnie K Black, RN · contact · autonomics@vumc.org · 615-343-6862
ContactLuis E Okamoto, MD · contact · autonomics@vumc.org · (615) 936-6119
InvestigatorItalo Biaggioni, MD · principal_investigator, Vanderbilt University Medical Center
All locations (1)
Autonomic Dysfunction Center/ Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States