Main
|
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 April 2024 |
Main ID: |
NCT02897063 |
Date of registration:
|
07/09/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
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/ct2/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:
|
Italo Biaggioni, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Vanderbilt University Medical Center |
|
Name:
|
Bonnie K Black, RN |
Address:
|
|
Telephone:
|
615-343-6862 |
Email:
|
autonomics@vumc.org |
Affiliation:
|
|
|
Name:
|
Emily C Smith, RN |
Address:
|
|
Telephone:
|
615-875-1516 |
Email:
|
autonomics@vumc.org |
Affiliation:
|
|
|
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
|
Parkinson Disease
|
Multiple System Atrophy
|
Orthostatic Hypotension
|
Autonomic Failure
|
Pure Autonomic Failure
|
Intervention(s)
|
Drug: Droxidopa
|
Drug: Placebo
|
Drug: Midodrine
|
Primary Outcome(s)
|
Stroke volume
[Time Frame: Up to 10 min of head up tilt]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|