Water and Sudafed in Autonomic Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT02149901
• Date of registration: 26/05/2014
• Prospective Registration: Yes
• Primary sponsor: Vanderbilt University
• Public title: Water and Sudafed in Autonomic Failure
• Scientific title: Effect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic Failure
• Date of first enrolment: October 2014
• Target sample size: 35
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02149901
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Emily M Garland, PhD, MSCI
• Affiliation: Vanderbilt University Medical Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Shy-Drager Syndrome

Intervention(s)

Other: Placebo + 50 ml water (optional)

Drug: Pseudoephedrine + 50 ml water

Other: Placebo + 480 ml water (optional)

Drug: Pseudoephedrine + 480 ml water

Primary Outcome(s)

The primary outcome measure in each Aim will be the peak increase in systolic blood pressure after pseudoephedrine or placebo relative to baseline (delta SBP). [Time Frame: between 60 and 120 minutes after pseudoephedrine or placebo]

Secondary Outcome(s)

Absolute systolic blood pressure after treatment [Time Frame: between 60 and 120 minutes after pseudoephedrine and placebo]

area under the curve for systolic blood pressure from baseline to 135 minutes post-treatment [Time Frame: from baseline to 135 minutes after pseudoephedrine or placebo]

Change in diastolic blood pressure relative to baseline [Time Frame: between 60 and 120 minutes after pseudoephedrine or placebo]

Absolute diastolic blood pressure after treatment [Time Frame: between 60 and 120 minutes after pseudoephedrine or placebo]

Peak plasma norepinephrine concentration after treatment [Time Frame: between baseline and 135 minutes after pseudoephedrine or placebo]

Change in heart rate relative to baseline [Time Frame: between 60 and 120 minutes after pseudoephedrine or placebo]

Secondary ID(s)

140547

P01HL056693

UL1TR000445

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Advancing Translational Science (NCATS)

National Heart, Lung, and Blood Institute (NHLBI)