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

NCT04620382 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 2016491R01HL144568-01A1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Failure; Neurogenic Orthostatic Hypotension; Pure Autonomic Failure; Parkinson Disease; Multiple System Atrophy

Keywords

midodrine; abdominal binder; splanchnic circulation; arterial stiffness

Outcome Measures

Primary Outcomes (1)

• Hemodynamic markers of cardiovascular risk

  augmentation index, central blood pressure, pulse wave velocity

  1 hour post-intervention tilt table test

Study Arms (2)

Midodrine

ACTIVE COMPARATOR

Single oral dose of midodrine (5-10mg) combined with sham abdominal compression

Drug: Midodrine; Device: sham compression

Abdominal Compression

EXPERIMENTAL

Abdominal compression (up to 40 mmHg) combined with a placebo pill

Drug: Placebo pill; Device: Abdominal compression

Interventions

Midodrine DRUG

Midodrine 5-10 mg, single oral dose

Midodrine

Placebo pill DRUG

single oral dose

Also known as: sugar pill

Abdominal Compression

Abdominal compression DEVICE

abdominal compression up to 40 mmHg during head-up tilt

Abdominal Compression

sham compression DEVICE

Sham abdominal compression during head-up tilt

Midodrine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pure Autonomic Failure; Multiple System Atrophy; Parkinson Disease

Interventions

Midodrine; Sugars

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinsonian Disorders

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Carbohydrates

Study Officials

• Luis Okamoto, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: placebo pill and sham abdominal compression will be used
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Randomized, single-blind, crossover

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 9, 2020
• Study Start: November 9, 2020
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)