Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Autonomic Failure; Supine Hypertension

Treatments: Drug: Placebo; Device: continuous positive airway pressure (CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03312556

010189-1

200124 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups, including a placebo group

Placebo pill or patch or sham CPAP

Placebo Comparator group

Description:

Placebo pill or patch or sham CPAP

Treatment:

Drug: Placebo

CPAP (continuous positive airway pressure)

Active Comparator group

Description:

Continuous positive airway pressure during the night

Treatment:

Device: continuous positive airway pressure (CPAP)