Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Not Applicable

Recruiting

• Conditions: Supine Hypertension; Autonomic Failure
• Interventions: Device: continuous positive airway pressure (CPAP); Drug: Placebo

• Registration Number: NCT03312556
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-31
• Primary Completion: 2026-09-21
• Study Completion: 2026-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients with autonomic failure and with supine hypertension from all races

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP (continuous positive airway pressure)	continuous positive airway pressure (CPAP)	Continuous positive airway pressure during the night
Placebo pill or patch or sham CPAP	Placebo	Placebo pill or patch or sham CPAP

Primary Outcome Measures

Name	Time	Method
Supine Systolic Blood Pressure	12 hours	change in supine systolic blood pressure from baseline

Secondary Outcome Measures

Name	Time	Method
Urinary volume	12 hours	Nocturnal urinary volume

Trial Locations

Locations (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States