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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: 8 February 2021
Main ID:  NCT04620382
Date of registration: 27/10/2020
Prospective Registration: Yes
Primary sponsor: Vanderbilt University Medical Center
Public title: Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
Scientific title: Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
Date of first enrolment: November 9, 2020
Target sample size: 31
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04620382
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Participant).  
Phase:  Early Phase 1
Countries of recruitment
United States
Contacts
Name:     Emily C Smith, RN BSN MPH
Address: 
Telephone: 615-875-1516
Email: emily.c.smith@vumc.org
Affiliation: 
Name:     Emily C Smith, RN
Address: 
Telephone: 615-875-1516
Email: emily.c.smith@vumc.org
Affiliation: 
Name:     Luis Okamoto, MD
Address: 
Telephone:
Email:
Affiliation:  Vanderbilt University Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects, age 40-80 years, with autonomic failure including pure
autonomic failure, multiple system atrophy and Parkinson disease.

- Neurogenic orthostatic hypotension, defined as a =20-mmHg decrease in SBP within 3
minutes of standing associated with impaired autonomic reflexes determined by
autonomic testing in the absence of other identifiable causes.

- Patients who are willing and able to provide informed consent

Exclusion Criteria:

- Pregnancy.

- Patients with any contraindication or intolerant to abdominal compression including
history of aortic aneurysms, thoracic, abdominal or pelvic surgery within 6 months of
study participation; symptomatic abdominal or inguinal hernias; severe
gastrointestinal 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.

- Pre-existing sustained supine hypertension =180/110mmHg

- Bedridden patients or those who are unable to stand due to motor impairment or severe
OH.

- Patients who cannot tolerate the medication withdrawal, defined as those who are
unable to stand for at least one minute after the medication withdrawal period or
those with sustained supine hypertension =180/110mmHg.

- Clinically unstable coronary artery disease, or major cardiovascular or neurological
event in the past 6 months.

- Clinically significant pulmonary, renal, hematopoietic, hepatic disease, or 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
Neurogenic Orthostatic Hypotension
Parkinson Disease
Pure Autonomic Failure
Intervention(s)
Device: Abdominal compression
Device: sham compression
Drug: Midodrine
Drug: Placebo pill
Primary Outcome(s)
Hemodynamic markers of cardiovascular risk [Time Frame: 1 hour post-intervention tilt table test]
Secondary Outcome(s)
Secondary ID(s)
1R01HL144568-01A1
201649
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Heart, Lung, and Blood Institute (NHLBI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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