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Treatment of Supine Hypertension in Autonomic Failure (CPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03312556
Recruitment Status : Suspended (Recruitment is temporarily suspended due to COVID-19 outbreak)
First Posted : October 17, 2017
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Supine Hypertension Autonomic Failure Device: continuous positive airway pressure (CPAP) Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : September 21, 2021
Estimated Study Completion Date : December 21, 2021


Arm Intervention/treatment
Placebo Comparator: Placebo pill or patch or sham CPAP
Placebo pill or patch or sham CPAP
Drug: Placebo
Placebo pill or patch. Single dose
Other Name: 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 Name: CPAP




Primary Outcome Measures :
  1. Supine Systolic Blood Pressure [ Time Frame: 12 hours ]
    change in supine systolic blood pressure from baseline


Secondary Outcome Measures :
  1. Urinary volume [ Time Frame: 12 hours ]
    Nocturnal urinary volume



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312556


Locations
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United States, Tennessee
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Italo Biaggioni, MD Vanderbilt University Medical Center
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Responsible Party: Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03312556    
Other Study ID Numbers: 010189-1
200124 ( Other Identifier: Vanderbilt IRB )
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Italo Biaggioni, Vanderbilt University Medical Center:
hypertension
supine hypertension
autonomic failure
pure autonomic failure
multiple system atrophy
cpap
Additional relevant MeSH terms:
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Pure Autonomic Failure
Hypertension
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases