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NCT Number: NCT03312556

Treatment of Supine Hypertension in Autonomic Failure (CPAP)

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Alfredo Gamboa, MD

SUB_INVESTIGATOR

Andre Diedrich, MD, PhD

SUB_INVESTIGATOR

Bonnie K Black, RN

CONTACT

[email protected]

615-343-6862

Bonnie K Black, RN

SUB_INVESTIGATOR

Cyndya A Shibao, MD

SUB_INVESTIGATOR

David Robertson, MD

SUB_INVESTIGATOR

Emily C Smith, RN

CONTACT

[email protected]

615-875-1516

Italo Biaggioni, MD

PRINCIPAL_INVESTIGATOR

Luis E Okamoto, MD

SUB_INVESTIGATOR

jorge Celedonio, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

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

Placebo

Drug

Placebo pill or patch. Single dose

Other names: placebo pill or patch

Primary outcomes

  1. Supine Systolic Blood Pressure

    Time frame: 12 hours

    change in supine systolic blood pressure from baseline

Secondary outcomes

  1. Urinary volume

    Time frame: 12 hours

    Nocturnal urinary volume

Study contacts

Contact information is provided by the study sponsor or research team.

Bonnie K Black, RN

CONTACT

[email protected]

615-343-6862

Luis E Okamoto, MD

CONTACT

[email protected]

(615) 936-6119

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Oct 17, 2017
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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