Water and Sudafed in Autonomic Failure

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Shy-Drager Syndrome, Multiple System Atrophy

In brief

The specific aim of this study is to determine whether water ingestion potentiates the pressor response to pseudoephedrine in patients with primary disorders of autonomic failure. The study design will enable us to also evaluate the pressor response to water alone and to pseudoephedrine alone. In a secondary analysis, we will compare the results in patients with two autonomic disorders, pure autonomic failure (PAF) and multiple system atrophy (MSA). We hypothesize that drinking water following a dose of pseudoephedrine will lead to a greater increase in blood pressure than pseudoephedrine alone.

Key facts

Study ID

NCT02149901

Run by

Vanderbilt University

People needed

35

Starts

2014-10-01

Expected to finish

2020-12-01

Last updated by the study team

2021-05-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80 years, with
• Neurogenic orthostatic hypotension, ≥30 mmHg drop in SBP within 5 minutes of standing,
• Associated with impaired autonomic reflexes, as determined by absence of blood pressure overshoot during phase IV of the valsalva maneuver,
• Absence of other identifiable causes of autonomic neuropathy, and
• Able and willing to provide informed consent

You may not qualify if…

• Pregnancy
• Current smoking habit
• Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.
• Known intolerance to pseudoephedrine
• Pre-existing sustained severe hypertension (BP > 180/110 mmHg in the sitting position)
• Clinically unstable coronary artery disease or major cardiovascular or neurological event in the past 6 months.
• Any other significant systemic, hepatic, cardiac or renal illness
• Use of MAO-I (i.e. selegiline; rasagiline - Azilect, linezolid and others) within 14 days
• Known closed-angle glaucoma
• Clinically meaningful arrhythmias
• Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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