Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02429557
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University

Brief Summary:
Compression garments have been shown to be effective in the treatment of orthostatic hypotension in autonomic failure patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt.

Condition or disease Intervention/treatment Phase
Orthostatic Hypotension Pure Autonomic Failure Multiple System Atrophy Autonomic Failure Other: Abdominal compression Other: Sham abdominal compression Drug: Placebo pill Drug: midodrine Phase 1

Detailed Description:

Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing) due to severe impairment of the autonomic nervous system. Compression garments such as waist-high stockings and abdominal binders have been shown to improve orthostatic hypotension in these patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt. This study will help us better understand the contribution of the abdominal veins to orthostatic hypotension and the mechanisms underlying this non-pharmacological therapeutic approach.

Participants will be studied in a tilt table in two separate days in a randomized, crossover fashion with sham abdominal compression (~5 mmHg) and active compression (~40 mmHg).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
Study Start Date : April 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Abdominal compression and placebo pill
Abdominal compression with an inflatable abdominal binder (up to 40 mmHg) during head up tilt, and placebo pill given 1 hour before the second head up tilt
Other: Abdominal compression
Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt
Other Name: abdominal binder

Drug: Placebo pill
Placebo pill given 1 hour before the second heat up tilt

Sham Comparator: Sham abdominal compression and placebo
Sham abdominal compression with an inflatable abdominal binder (~5 mmHg) during head up tilt, and placebo pill given 1 hour before the second head up tilt
Other: Sham abdominal compression
Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt
Other Name: abdominal binder

Drug: Placebo pill
Placebo pill given 1 hour before the second heat up tilt

Experimental: Abdominal compression and midodrine
Abdominal compression with an inflatable abdominal binder (up to 40 mmHg) during head up tilt, and midodrine 2.5-10 mg PO given 1 hour before the second head up tilt
Other: Abdominal compression
Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt
Other Name: abdominal binder

Drug: midodrine
Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt
Other Name: ProAmatine

Active Comparator: Sham abdominal compression and midodrine
Sham abdominal compression with an inflatable abdominal binder (~5 mmHg) during head up tilt, and midodrine 2.5-10mg PO given 1 hour before the second head up tilt
Other: Sham abdominal compression
Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt
Other Name: abdominal binder

Drug: midodrine
Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt
Other Name: ProAmatine




Primary Outcome Measures :
  1. Stroke volume [ Time Frame: an average of 15 minutes of head up tilt ]
    Percent change from supine in stroke volume during head up tilt


Secondary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: an average of 15 minutes of head up tilt ]
    Change from baseline in systolic blood pressure during head up tilt

  2. Splanchnic vascular volume [ Time Frame: an average of 15 minutes of head up tilt ]
    Percent change from supine in splanchnic vascular volume during head up tilt.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients,
  • between 18-80 yrs.,
  • with neurogenic orthostatic hypotension associated with primary autonomic failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure). Orthostatic hypotension will be defined as ≥20 mmHg decrease in systolic BP or ≥10 mmHg of diastolic BP within 3 minutes on standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes (Freeman et al., 2011).
  • Patients able and willing to provide informed consent.

Exclusion Criteria:

  • Pregnancy.
  • Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or external abdominal compression will be excluded.
  • Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months, and; other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing

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): NCT02429557


Contacts
Layout table for location contacts
Contact: Emily C Smith, RN 615.875.1516 autonomics@vumc.org
Contact: Bonnie K Black, RN 615-322-3304 autonomics@vumc.org

Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Emily C Smith, RN    615-875-1516    autonomics@vumc.org   
Contact: Bonnie K Black, RN    615-322-3304    autonomics@vumc.org   
Principal Investigator: Italo Biaggioni, MD         
Sub-Investigator: Alfredo Gamboa, MD         
Sub-Investigator: Luis E Okamoto, MD         
Sub-Investigator: Cyndya A Shibao, MD         
Sub-Investigator: Andre Diedrich, MD/PhD         
Sub-Investigator: Emily C Smith, RN         
Sponsors and Collaborators
Vanderbilt University
Investigators
Layout table for investigator information
Principal Investigator: Italo Biaggioni, MD Vanderbilt University

Layout table for additonal information
Responsible Party: Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02429557     History of Changes
Other Study ID Numbers: 140634
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Keywords provided by Italo Biaggioni, Vanderbilt University:
autonomic failure
orthostatic hypotension
compression garments
treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple System Atrophy
Shy-Drager Syndrome
Brain Diseases
Hypotension, Orthostatic
Pure Autonomic Failure
Hypotension
Atrophy
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action