Treatment of Supine Hypertension in Autonomic Failure (CPAP)
Primary Purpose
Supine Hypertension, Autonomic Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continuous positive airway pressure (CPAP)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Supine Hypertension focused on measuring hypertension, supine hypertension, autonomic failure, pure autonomic failure, multiple system atrophy, cpap
Eligibility Criteria
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.
Sites / Locations
- Autonomic Dysfunction Center/ Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo pill or patch or sham CPAP
CPAP (continuous positive airway pressure)
Arm Description
Placebo pill or patch or sham CPAP
Continuous positive airway pressure during the night
Outcomes
Primary Outcome Measures
Supine Systolic Blood Pressure
change in supine systolic blood pressure from baseline
Secondary Outcome Measures
Urinary volume
Nocturnal urinary volume
Full Information
NCT ID
NCT03312556
First Posted
October 12, 2017
Last Updated
March 17, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03312556
Brief Title
Treatment of Supine Hypertension in Autonomic Failure (CPAP)
Official Title
Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
September 21, 2024 (Anticipated)
Study Completion Date
December 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supine Hypertension, Autonomic Failure
Keywords
hypertension, supine hypertension, autonomic failure, pure autonomic failure, multiple system atrophy, cpap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo pill or patch or sham CPAP
Arm Type
Placebo Comparator
Arm Description
Placebo pill or patch or sham CPAP
Arm Title
CPAP (continuous positive airway pressure)
Arm Type
Active Comparator
Arm Description
Continuous positive airway pressure during the night
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure (CPAP)
Other Intervention Name(s)
CPAP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo pill or patch
Intervention Description
Placebo pill or patch. Single dose
Primary Outcome Measure Information:
Title
Supine Systolic Blood Pressure
Description
change in supine systolic blood pressure from baseline
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Urinary volume
Description
Nocturnal urinary volume
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily C Smith, RN
Phone
615.875.1516
Email
autonomics@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie K Black, RN
Phone
615-343-6862
Email
autonomics@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily C Smith, RN
Phone
615-875-1516
Email
autonomics@vumc.org
First Name & Middle Initial & Last Name & Degree
Bonnie K Black, RN
Phone
615-343-6862
Email
autonomics@vumc.org
First Name & Middle Initial & Last Name & Degree
Bonnie K Black, RN
First Name & Middle Initial & Last Name & Degree
Luis E Okamoto, MD
First Name & Middle Initial & Last Name & Degree
David Robertson, MD
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
First Name & Middle Initial & Last Name & Degree
Alfredo Gamboa, MD
First Name & Middle Initial & Last Name & Degree
Cyndya A Shibao, MD
First Name & Middle Initial & Last Name & Degree
Andre Diedrich, MD, PhD
First Name & Middle Initial & Last Name & Degree
jorge Celedonio, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Treatment of Supine Hypertension in Autonomic Failure (CPAP)
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