Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Autonomic Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03312556
• Other study ID #: 010189-1
• Secondary ID: 200124
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: December 21, 2024

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Bonnie K Black, RN
• Phone: 615-343-6862
• Email: autonomics[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 21, 2024
• Est. primary completion date: September 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Failure
• Hypertension
• Pure Autonomic Failure
• Supine Hypertension

Intervention

Device:
• continuous positive airway pressure (CPAP)
Continuous positive airway pressure(CPAP) will be applied during the night starting from 20:00. CPAP level will be determined during an acute CPAP trial.

Drug:
• Placebo
Placebo pill or patch. Single dose

Locations

Country	Name	City	State
United States	Autonomic Dysfunction Center/ Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supine Systolic Blood Pressure	change in supine systolic blood pressure from baseline	12 hours
Secondary	Urinary volume	Nocturnal urinary volume	12 hours