Using CPAP to treat high blood pressure in patients with autonomic failure

Hemodynamic Effects of Positive Airway Pressure to Treat Supine Hypertension and Improve Neurogenic Orthostatic Hypotension

This study tests if using a CPAP machine can help people with autonomic failure lower their nighttime blood pressure when they lie down.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 59 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT05489575 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of continuous positive airway pressure (CPAP) on individuals with autonomic failure who experience high blood pressure while lying down, known as supine hypertension. Participants will undergo a series of tests at the Vanderbilt Clinical Research Center, including both daytime and overnight assessments with active and sham CPAP treatments. The study aims to determine if CPAP can effectively lower nighttime blood pressure in these patients. Measurements will include blood pressure, heart rate, and other cardiovascular parameters during the interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-80 with autonomic failure conditions such as pure autonomic failure, multiple system atrophy, or Parkinson disease who experience nocturnal supine hypertension.

Not a fit: Patients with recent facial trauma, intolerance to CPAP, or those who are bedridden may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for managing high blood pressure in patients with autonomic failure.

How similar studies have performed: While the use of CPAP is well-established for sleep apnea, its application for treating supine hypertension in autonomic failure is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease.
* Neurogenic orthostatic hypotension, defined as a ≥20-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
* Nocturnal supine hypertension (nighttime systolic blood pressure ≥140 mmHg) during the overnight screening for supine hypertension.
* Patients who are willing and able to provide informed consent

Exclusion Criteria:

* Patients with history of recent facial trauma or surgery or intolerance to CPAP or to the CPAP mask.
* Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute or those with sustained supine blood pressure ≥180/110 mmHg after the medication withdrawal period.
* Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.
* Smokers, patients who are pregnant, or have clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months; heart failure; and other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical or laboratory testing.

Where this trial is running

Nashville, Tennessee

• Autonomic Dysfunction Center/ Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)

Study contacts

• Principal investigator: Italo Biaggioni, MD — Vanderbilt University Medical Center
• Study coordinator: Bonnie K Black, RN, NP

Conditions: Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease, Supine Hypertension, Neurogenic Orthostatic Hypotension, CPAP, Hypertension