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Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic

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ClinicalTrials.gov Identifier: NCT02726711
Recruitment Status : Recruiting
First Posted : April 4, 2016
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University

Brief Summary:
The purpose of this study is to learn more about the regulation of the veins of the abdomen by the autonomic (involuntary) nervous system, and how this may affect high blood pressure. Normally, the autonomic nervous system controls how much blood flows in the veins. In people with high blood pressure, however, the autonomic nervous system is changed. This change may affect the way blood flows in the veins of the abdomen which may play a role in their high blood pressure. About 32 participants will be screened for the study. The investigators estimate 16 will be eligible to participate in all of the study days.

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Orthostatic Hypotension Supine Hypertension Drug: Trimethaphan Drug: Placebo Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic Aim 1 of Rare Diseases Clinical Research Network (RDCRN) Project 2
Study Start Date : April 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: Trimethaphan

The investigator will measure cardiac output by studying the air the participant breathes in and out. The participant will also wear a facemask to apply a low air pressure to the airway.

After this, the trimethaphan infusion will begin with a small dose and the investigators increase at 1-2 minute intervals for up to five doses. The measurements will be collected again.

Next, a standard blood pressure cuffs will be wrapped around the participant's abdomen. the cuff will inflate to apply pressure for 5 - 15 minutes.

Drug: Trimethaphan
Trimethaphan will be infused (0.5 - 4.0 mg IV)
Other Name: Trimethaphan Camsylate

Placebo Comparator: Placebo

The investigator will measure cardiac output by studying the air the participant breathes in and out. The participant will also wear a facemask to apply a low air pressure to the airway.

After this, the placebo (saline) infusion will begin with a small dose and the investigators increase at 1-2 minute intervals for up to five doses. The measurements will be collected again.

Next, a standard blood pressure cuffs will be wrapped around the participant's abdomen. the cuff will inflate to apply pressure for 5 - 15 minutes.

Drug: Placebo
0.5 - 4.0 mg IV to be infused
Other Name: saline




Primary Outcome Measures :
  1. The percentage of increase of the y intercept of the P-V relationship [ Time Frame: 5 years ]
    To determine whether autonomic blockade with trimethaphan increases splanchnic capacitance (parallel upward shift in the P-V relationship) compared to placebo.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects, age 40-80 years, with possible or probable Multiple System Atrophy, as defined by Consensus Criteria.
  • Neurogenic orthostatic hypotension defined as a ≥30-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
  • Supine hypertension, defined as systolic blood pressure ≥150 mmHg measured on two separate occasions.
  • Subjects able and willing to provide informed consent.

Exclusion Criteria:

  • Pregnancy.
  • Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies
  • History of known aortic aneurysms, thoracic, abdominal or pelvic surgery in the past 6 months
  • Symptomatic abdominal or inguinal hernias
  • Severe gastroesophageal reflux
  • Recent fractures or fissures of ribs, thoracic or lumbar spine
  • Medical devices implanted on the abdominal wall or abdomen that would interfere with the abdominal compression
  • Intolerance to any increase in intra-abdominal pressure
  • 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): NCT02726711


Contacts
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Contact: Emily C Smith, RN 615.875.1516 autonomics@vumc.org
Contact: Bonnie K Black, RN 615-343-6862 autonomics@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Emily C Smith, RN    615-875-1516    autonomics@vumc.org   
Contact    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: David H Robertson, MD         
Sub-Investigator: Emily C Smith, RN         
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Italo Biaggioni, M.D. Vanderbilt University

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Responsible Party: Italo Biaggioni, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02726711     History of Changes
Other Study ID Numbers: 151947
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Multiple System Atrophy
Shy-Drager Syndrome
Hypertension
Hypotension
Atrophy
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Trimethaphan
Trimethaphan camsylate
Adjuvants, Anesthesia
Antihypertensive Agents
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents