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Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients

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ClinicalTrials.gov Identifier: NCT04620382
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Luis E Okamoto, Vanderbilt University Medical Center

Brief Summary:
The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular risk. The study will be conducted at the Vanderbilt University Medical Center and consists of a screening and 2 testing days, one with abdominal compression and one with midodrine. The total length of the study will be about 5 days.

Condition or disease Intervention/treatment Phase
Neurogenic Orthostatic Hypotension Autonomic Failure Pure Autonomic Failure Multiple System Atrophy Parkinson Disease Drug: Midodrine Drug: Placebo pill Device: Abdominal compression Device: sham compression Early Phase 1

Detailed Description:

The study includes up to 5 days spent in the Vanderbilt University Medical Center, at least one day of screening tests, followed by 2 study days.

Screening tests include a physical examination and history, routine safety laboratory assessments, and testing of the autonomic nervous system. Medications affecting blood pressure and the autonomic nervous system such as pressor medications will be withdrawn for at least 5 half-lives before studies, except for fludrocortisone. Other medications will be held constant throughout the study.

Eligible participants will then be studied on two separate days in random order: one day with midodrine combined with sham abdominal compression, and one day with abdominal compression combined with a placebo pill.

On each study day, participants will be instrumented to measure blood pressure, heart rate, hemodynamic parameters, segmental impedance, and markers of cardiovascular risk. A baseline tilt table test will be performed to obtain supine and upright baseline measurements, including the assessment of orthostatic symptoms. Participants will then receive a single oral dose of placebo or midodrine, and a deflated binder will be placed around the abdomen. Thirty to sixty minutes later, a second tilt table test will be done with sham or active abdominal compression. Outcome measurements will be repeated in the supine and upright positions. At the end of the second tilt table test, the investigators may also assess splanchnic venous capacitance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, single-blind, crossover
Masking: Single (Participant)
Masking Description: placebo pill and sham abdominal compression will be used
Primary Purpose: Other
Official Title: Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
Actual Study Start Date : November 9, 2020
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : December 1, 2024


Arm Intervention/treatment
Active Comparator: Midodrine
Single oral dose of midodrine (5-10mg) combined with sham abdominal compression
Drug: Midodrine
Midodrine 5-10 mg, single oral dose

Device: sham compression
Sham abdominal compression during head-up tilt

Experimental: Abdominal Compression
Abdominal compression (up to 40 mmHg) combined with a placebo pill
Drug: Placebo pill
single oral dose
Other Name: sugar pill

Device: Abdominal compression
abdominal compression up to 40 mmHg during head-up tilt




Primary Outcome Measures :
  1. Hemodynamic markers of cardiovascular risk [ Time Frame: 1 hour post-intervention tilt table test ]
    augmentation index, central blood pressure, pulse wave velocity



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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 autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease.
  • Neurogenic orthostatic hypotension, defined as a ≥20-mmHg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
  • Patients who are willing and able to provide informed consent

Exclusion Criteria:

  • Pregnancy.
  • Patients with any contraindication or intolerant to abdominal compression including history of aortic aneurysms, thoracic, abdominal or pelvic surgery within 6 months of study participation; symptomatic abdominal or inguinal hernias; severe gastrointestinal 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.
  • Pre-existing sustained supine hypertension ≥180/110mmHg
  • Bedridden patients or those who are unable to stand due to motor impairment or severe OH.
  • Patients who cannot tolerate the medication withdrawal, defined as those who are unable to stand for at least one minute after the medication withdrawal period or those with sustained supine hypertension ≥180/110mmHg.
  • Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months.
  • Clinically significant pulmonary, renal, hematopoietic, hepatic disease, or 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): NCT04620382


Contacts
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Contact: Emily C Smith, RN 615-875-1516 emily.c.smith@vumc.org
Contact: Luis Okamoto, MD 615-936-6119 luis.e.okamoto@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 BSN MPH    615-875-1516    emily.c.smith@vumc.org   
Contact: Luis E Okamoto, MD    6159366119    luis.e.okamoto@vumc.org   
Principal Investigator: Luis E Okamoto, MD         
Sub-Investigator: Andre Diedrich, MD PhD         
Sub-Investigator: Alfredo Gamboa, MD         
Sub-Investigator: Cyndya A Shibao, MD         
Sub-Investigator: Emily C Smith, RN MPH         
Sponsors and Collaborators
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Luis Okamoto, MD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Luis E Okamoto, Vanderbilt University Medical Center:
Informed Consent Form  [PDF] August 4, 2020

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Responsible Party: Luis E Okamoto, Research Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04620382    
Other Study ID Numbers: 201649
1R01HL144568-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Luis E Okamoto, Vanderbilt University Medical Center:
midodrine
abdominal binder
splanchnic circulation
arterial stiffness
Additional relevant MeSH terms:
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Parkinson Disease
Hypotension, Orthostatic
Multiple System Atrophy
Shy-Drager Syndrome
Pure Autonomic Failure
Hypotension
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System 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