The Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2

Trial ID: NCT02897063

Interventional - Phase 1 - Recruiting

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.

Conditions

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

Interventions

• Droxidopa
• Midodrine
• Placebo

Eligibility

Inclusion criteria

• 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 criteria

• 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.

Sponsor

Vanderbilt University Medical Center

Source: ClinicalTrials.gov

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