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Accelerometer Monitoring for Neurogenic Orthostatic Hypotension

N/A
Recruiting
Led By Italo Biaggioni, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Possible or probable Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension.
Male and female subjects, age 40-80 years
Must not have
Bedridden, physically disabled, or unable to walk
Patients with Orthostatic hypotension symptom assessment (OHSA) score ≥ 6, or orthostatic systolic blood pressure drop ≥ 30 mmHg on their regular treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days of treatment or placebo period

Summary

This trial is looking for a more objective way to assess the efficacy of treatments for neurogenic orthostatic hypotension, by using an activity monitor to track how long patients spend in the upright position during a week on placebo and a week on their regular medication.

Who is the study for?
This trial is for people aged 40-80 with conditions like Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease who have low blood pressure upon standing. They must be on midodrine or atomoxetine treatment and not bedridden, pregnant, or have had recent major cardiovascular events.
What is being tested?
The study tests if an accelerometer can better measure the effectiveness of treatments for neurogenic orthostatic hypotension compared to questionnaires. Participants will take either their regular medication or a placebo pill while wearing the activity monitor.
What are the potential side effects?
Midodrine may cause scalp tingling, chills, urinary urgency; Atomoxetine might lead to dry mouth, insomnia, increased heart rate. Placebos typically do not cause side effects but can trigger a psychological response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a condition that causes low blood pressure when I stand.
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I am between 40 and 80 years old.
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I am taking medication for low blood pressure upon standing and still have symptoms.
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I experience significant drops in blood pressure upon standing due to a nerve condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to walk or am bedridden.
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I experience significant dizziness or a drop in blood pressure when standing.
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I am currently taking blood thinners.
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I haven't had a heart attack, stroke, or severe chest pain in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days of treatment or placebo period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days of treatment or placebo period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Orthostatic symptoms
Total standing time measured by an accelerometer
Secondary study objectives
Total number of steps measured by an accelerometer
Total walking time measured by an accelerometer

Side effects data

From 2022 Phase 2 trial • 92 Patients • NCT02713126
59%
Dizziness
54%
Miscellaneous - Blister/Bloody nose/Cataract/Dry Mouth/Acne
41%
Muscle and Joint Pain
35%
Cold/SoreThroat/Flu
32%
Upset stomach/diarrhea
30%
Chest pain
27%
Cough
27%
Shortness of Breath
27%
Headache
19%
General Minor Injury - Fall/Bruise/Cut
14%
Nausea
8%
Fatigue
5%
Mood Changes - Depressed/Edgy/Forgetful
5%
Rash
5%
Pneumonia
5%
Edema
5%
Bad Taste in Mouth
5%
Weight Gain
5%
Arrhythmia
5%
Severe Chest/Neck/Jaw Pain
3%
Shortness of Breath - Worsening Heart Failure
3%
Syncope/Stent placement
3%
Black Stool
3%
Worsening Renal Function
3%
Revascularization
3%
Numbness/Pins and Needles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sodium Nitrite

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: placeboExperimental Treatment2 Interventions
Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
Group II: Standard treatmentActive Control2 Interventions
Either midodrine or atomoxetine at their regular dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Accelerometer
2022
Completed Phase 2
~590
placebo pill
2005
Completed Phase 4
~350

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
901 Previous Clinical Trials
938,653 Total Patients Enrolled
Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
28 Previous Clinical Trials
1,425 Total Patients Enrolled

Media Library

Midodrine or atomoxetine pill (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04782830 — N/A
Neurogenic Orthostatic Hypotension Research Study Groups: placebo, Standard treatment
Neurogenic Orthostatic Hypotension Clinical Trial 2023: Midodrine or atomoxetine pill Highlights & Side Effects. Trial Name: NCT04782830 — N/A
Midodrine or atomoxetine pill (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782830 — N/A
~3 spots leftby Jun 2025
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