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Midodrine and Droxidopa for Autonomic Failure and Orthostatic Hypotension

This study is investigating how two medications, midodrine and droxidopa, affect blood flow in the abdomen of people with autonomic failure. Autonomic failure is a condition where the body's automatic functions, like blood pressure control, don't work properly. The goal is to understand how these drugs help with orthostatic hypotension (low blood pressure when standing up). You might be able to join if you are 40-80 years old and have conditions like Multiple System Atrophy, Pure Autonomic Failure, or Parkinson's disease, along with neurogenic orthostatic hypotension. The study is currently unclear on its recruitment status and aims to measure stroke volume (the amount of blood pumped by the heart with each beat) during a head-up tilt test.

Study design
This study is designed as a randomized, double-blind trial with two groups, enrolling about 34 participants (17 in each group). Participants will receive either droxidopa or midodrine, and also a placebo (sugar pill).
What's involved
You would undergo a screening process at Vanderbilt University Medical Center, followed by two separate testing days, two days apart. The total study length is about 5 days.
Compensation
Not stated in the trial record.
Follow-up
Stroke volume is measured up to 10 minutes after a head-up tilt, but no further follow-up is specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02897063

Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

Recruiting
PHASE1Ages 40–80InterventionalBasic science
Vanderbilt University Medical Center
~34 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:DroxidopaMidodrinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stroke volume
Measured over Up to 10 min of head up tilt

Conditions

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

Explore related trials

Multiple System AtrophyOrthostatic HypotensionParkinson DiseasePure autonomic failure

NCT02897063

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Autonomic Dysfunction Center/ Vanderbilt University Medical Center

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Italo Biaggioni, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Bonnie K Black, RN
[email protected]
615-343-6862
Email the study team

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Eligibility criteria

Inclusion

Male and female subjects, age 40-80 years with possible or probable Multiple System Atrophy, Pure Autonomic Failure, or Parkinson disease, 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.
Subjects able and willing to provide informed consent.

Exclusion

Supine hypertension, defined as systolic blood pressure of ≥ 160 mmHg measured on two separate occasions.
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 aneurisms, 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 intraabdominal 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.

What this trial measures

  • Stroke volumeUp to 10 min of head up tilt

    The primary outcome will be the percent change from supine in stroke volume during HUT