Clinical trial NCT03312556: Treatment of Supine Hypertension in Autonomic Failure (CPAP)
Official title: Treatment of Supine Hypertension in Autonomic Failure with Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supine Hypertension
Autonomic Failure
Keywords: hypertension
supine hypertension
autonomic failure
pure autonomic failure
multiple system atrophy
cpap
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Supine Systolic Blood Pressure
timeFrame: 12 hours
Secondary outcomes:
measure: Urinary volume
timeFrame: 12 hours
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Autonomic Dysfunction Center/ Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Italo Biaggioni, MD
role: PRINCIPAL_INVESTIGATOR
References: