Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorVanderbilt University Medical Center

About this trial

The purpose of this study is to learn more about the effects of midodrine and droxidopa, two medications used for the treatment of orthostatic hypotension (low blood pressure on standing), on the veins of the abdomen of patients with autonomic failure. The study will be conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and 2 testing days. The total length of the study will be about 5 days. About 34 participants will be screened for the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Droxidopa

    Drug

    Single oral dose 300 mg

  • Midodrine

    Drug

    Single oral dose 10 mg

  • Placebo

    Drug

    sugar pill

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Droxidopa and PlaceboExperimental treatment 2 interventions
Group B: Midodrine and PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Stroke volume

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

Time frame
Up to 10 min of head up tilt

Secondary outcomes

Other outcomes

Sponsors and contacts

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