Treatment of Supine Hypertension in Autonomic Failure (CPAP)
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2017
CompletedFirst Submitted
Initial submission to the registry
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 21, 2026
November 6, 2025
November 1, 2025
9 years
October 12, 2017
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Supine Systolic Blood Pressure
change in supine systolic blood pressure from baseline
12 hours
Secondary Outcomes (1)
Urinary volume
12 hours
Study Arms (2)
Placebo pill or patch or sham CPAP
PLACEBO COMPARATORPlacebo pill or patch or sham CPAP
CPAP (continuous positive airway pressure)
ACTIVE COMPARATORContinuous positive airway pressure during the night
Interventions
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.
Placebo pill or patch. Single dose
Eligibility Criteria
You may qualify if:
- Patients with autonomic failure and with supine hypertension from all races
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Okamoto LE, Celedonio JE, Smith EC, Paranjape SY, Black BK, Wahba A, Park JW, Shibao CA, Diedrich A, Biaggioni I. Continuous Positive Airway Pressure for the Treatment of Supine Hypertension and Orthostatic Hypotension in Autonomic Failure. Hypertension. 2023 Mar;80(3):650-658. doi: 10.1161/HYPERTENSIONAHA.122.20081. Epub 2023 Jan 5.
PMID: 36601916DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Italo Biaggioni, MD
Vanderbilt University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine and Pharmacology
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 17, 2017
Study Start
September 21, 2017
Primary Completion (Estimated)
September 21, 2026
Study Completion (Estimated)
December 21, 2026
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share