- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312556
Treatment of Supine Hypertension in Autonomic Failure (CPAP)
Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bonnie K Black, RN
- Phone Number: 615-343-6862
- Email: autonomics@vumc.org
Study Contact Backup
- Name: Luis E Okamoto, MD
- Phone Number: (615) 936-6119
- Email: autonomics@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Autonomic Dysfunction Center/ Vanderbilt University Medical Center
-
Contact:
- Bonnie K Black, RN
- Phone Number: 615-343-6862
- Email: autonomics@vumc.org
-
Sub-Investigator:
- David Robertson, MD
-
Sub-Investigator:
- jorge Celedonio, MD
-
Contact:
- Emily C Smith, RN
- Phone Number: 615-875-1516
- Email: autonomics@vumc.org
-
Sub-Investigator:
- Bonnie K Black, RN
-
Sub-Investigator:
- Luis E Okamoto, MD
-
Principal Investigator:
- Italo Biaggioni, MD
-
Sub-Investigator:
- Alfredo Gamboa, MD
-
Sub-Investigator:
- Cyndya A Shibao, MD
-
Sub-Investigator:
- Andre Diedrich, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo pill or patch or sham CPAP
|
Placebo pill or patch.
Single dose
Other Names:
|
Active Comparator: CPAP (continuous positive airway pressure)
Continuous positive airway pressure during the night
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Supine Systolic Blood Pressure
Time Frame: 12 hours
|
change in supine systolic blood pressure from baseline
|
12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary volume
Time Frame: 12 hours
|
Nocturnal urinary volume
|
12 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Italo Biaggioni, MD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010189-1
- 200124 (Other Identifier: VUMC IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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