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

What this Trial Is About

Supine hypertension, a condition affecting at least half of patients with primary autonomic failure, can be severe and complicates treatment for orthostatic hypotension. This research aims to find out whether using continuous positive airway pressure (CPAP) can lower blood pressure in patients with autonomic failure who have supine hypertension. The mechanisms causing this condition are not fully understood, and current drugs may worsen the problem or cause organ damage. The study is sponsored by Vanderbilt University Medical Center and is interventional in design. The study evaluates two treatment approaches: one group receives placebo pills, patches, or sham CPAP, while the other group uses CPAP during the night. An acute CPAP trial determines the appropriate pressure level, which is then applied overnight starting from 8:00 PM. The CPAP device delivers air pressure through a mask to keep airways open, with pressure levels tested sequentially at 0, 4, 8, 12, and 16 cm H2O for 1 to 20 minutes each to assess blood pressure response and tolerability. Participants will be monitored for changes in their supine systolic blood pressure over a 12-hour period, which is the primary outcome measure. Secondary measures include urinary volume over 12 hours. The study involves randomized allocation without masking or blinding. Participants undergo blood pressure assessments during the acute CPAP trial and may continue with CPAP overnight if tolerated. The trial excludes healthy volunteers and runs until December 2026, with participants ranging from 18 to 85 years old.

Treatment of Supine Hypertension in Autonomic Failure (CPAP)