Water and Sudafed in Autonomic Failure

• Status: Terminated
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborators: National Center for Advancing Translational Science (NCATS); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Ephedrine; Pseudoephedrine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria

• 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