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

NCT04620382 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-05-05

No results posted yet for this study

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

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

Interventions

DEVICE

sham compression

Sham abdominal compression during head-up tilt

DRUG

Midodrine

Midodrine 5-10 mg, single oral dose

DRUG

Placebo pill

single oral dose

DEVICE

Abdominal compression

abdominal compression up to 40 mmHg during head-up tilt

Sponsors & Collaborators

Principal Investigators

  • Luis Okamoto, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2025-07-01
Completion
2025-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04620382 on ClinicalTrials.gov