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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02897063
Date of registration: 07/09/2016
Prospective Registration: Yes
Primary sponsor: Vanderbilt University Medical Center
Public title: Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
Scientific title: The Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2
Date of first enrolment: September 2016
Target sample size: 34
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02897063
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Emily C Smith, RN
Address: 
Telephone: 615-875-1516
Email: autonomics@vumc.org
Affiliation: 
Name:     Emily C Smith, RN
Address: 
Telephone: 615.875.1516
Email: autonomics@vumc.org
Affiliation: 
Name:     Italo Biaggioni, MD
Address: 
Telephone:
Email:
Affiliation:  Vanderbilt University Medical Center
Key inclusion & exclusion criteria

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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Autonomic Failure
Multiple System Atrophy
Orthostatic Hypotension
Parkinson Disease
Pure Autonomic Failure
Intervention(s)
Drug: Droxidopa
Drug: Midodrine
Drug: Placebo
Primary Outcome(s)
Stroke volume [Time Frame: Up to 10 min of head up tilt]
Secondary Outcome(s)
Secondary ID(s)
160255
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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