Treatment of Supine Hypertension in Autonomic Failure (CPAP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Supine Hypertension; Autonomic Failure
• Intervention / Treatment: Drug: Placebo; Device: continuous positive airway pressure (CPAP)

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: Interventional
• Enrollment (Estimated): 12
• 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

• United States
  • 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: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Italo Biaggioni, MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): December 21, 2026

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; autonomic failure; multiple system atrophy; pure autonomic failure; supine hypertension; cpap
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypertension; Multiple System Atrophy; Pure Autonomic Failure; Microcephaly, Primary Autosomal Recessive, 6; Therapeutics; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure
• Other Study ID Numbers: 010189-1; 200124 (Other Identifier: VUMC IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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