Treatment of Supine Hypertension in Autonomic Failure (CPAP)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Supine Hypertension, Autonomic Failure

Intervention / Treatment
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* Device: continuous positive airway pressure (CPAP)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo pill or patch or sham CPAP<br>Placebo pill or patch or sham CPAP | Drug: Placebo<br>* Placebo pill or patch. Single dose<br>* Other names: placebo pill or patch;|
| Active Comparator: CPAP (continuous positive airway pressure)<br>Continuous positive airway pressure during the night | Device: continuous positive airway pressure (CPAP)<br>* 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.<br>* Other names: CPAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supine Systolic Blood Pressure | change in supine systolic blood pressure from baseline | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary volume | Nocturnal urinary volume | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, supine hypertension, autonomic failure, pure autonomic failure, multiple system atrophy, cpap