Neurogenic Orthostatic HypotensionEarly Phase 1NCT04620382
Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
A Early Phase 1 study testing Midodrine and Abdominal compression in people with Neurogenic Orthostatic Hypotension and Autonomic Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular risk. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Neurogenic Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure
- What is being tested?
- Midodrine and Abdominal compression
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 1 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular risk. The study will be conducted at the Vanderbilt University Medical Center and consists of a screening and 2 testing days, one with abdominal compression and one with midodrine. The total length of the study will be about 5 days.
Read the detailed description
The study includes up to 5 days spent in the Vanderbilt University Medical Center, at least one day of screening tests, followed by 2 study days.
Screening tests include a physical examination and history, routine safety laboratory assessments, and testing of the autonomic nervous system. Medications affecting blood pressure and the autonomic nervous system such as pressor medications will be withdrawn for at least 5 half-lives before studies, except for fludrocortisone. Other medications will be held constant throughout the study.
Eligible participants will then be studied on two separate days in random order: one day with midodrine combined with sham abdominal compression, and one day with abdominal compression combined with a placebo pill.
On each study day, participants will be instrumented to measure blood pressure, heart rate, hemodynamic parameters, segmental impedance, and markers of cardiovascular risk. A baseline tilt table test will be performed to obtain supine and upright baseline measurements, including the assessment of orthostatic symptoms. Participants will then receive a single oral dose of placebo or midodrine, and a deflated binder will be placed around the abdomen. Thirty to sixty minutes later, a second tilt table test will be done with sham or active abdominal compression. Outcome measurements will be repeated in the supine and upright positions. At the end of the second tilt table test, the investigators may also assess splanchnic venous capacitance.
- Conditions
- Neurogenic Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease
- Being tested
- Midodrine, Placebo pill, Abdominal compression, sham compression
- Keywords
- midodrine, abdominal binder, splanchnic circulation, arterial stiffness
- Medical subject headings
- Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Midodrine 5-10 mg, single oral dose
Placebo pillDrug
Also called sugar pill
single oral dose
Abdominal compressionDevice
abdominal compression up to 40 mmHg during head-up tilt
sham compressionDevice
Sham abdominal compression during head-up tilt
| Study group | Role | What they receive |
|---|---|---|
| Midodrine day followed by abdominal compression day | Experimental | Single oral dose of midodrine (5-10mg) combined with sham abdominal compression on the first study day followed by active abdominal compression (40 mmHg) combined with placebo pill. Receives: Drug: Midodrine; Device: sham compression |
| Abdominal Compression study day followed by midodrine study day | Experimental | Study day with abdominal compression (40 mmHg) combined with a placebo pill followed by study day with a single oral dose of midodrine (5-10mg) combined with sham abdominal compression. Receives: Drug: Placebo pill; Device: Abdominal compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Augmentation Index
Change from baseline in upright augmentation index, used as a marker of cardiovascular risk associated with systemic arterial stiffness, wave reflection, and the resulting pulsatile workload imposed on the left ventricle. Higher values suggest greater risk.
Measured: 1 hour post-intervention tilt table test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start9 Nov 2020
- Primary completion1 Jul 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurogenic Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, single-blind, crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Luis E Okamoto, Vanderbilt University Medical Center
- Investigators
- Luis Okamoto, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620382
- Sponsor's protocol ID
- 201649
- Other IDs
- 1R01HL144568-01A1
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2020
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
- ClinicalTrials.gov ID
- NCT04620382
- Acronym / sponsor ID
- 201649
- Conditions
- Neurogenic Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy, Parkinson Disease
- Keywords
- midodrine, abdominal binder, splanchnic circulation, arterial stiffness
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular risk. The study will be conducted at the Vanderbilt University Medical Center and consists of a screening and 2 testing days, one with abdominal compression and one with midodrine. The total length of the study will be about 5 days.
Detailed description
The study includes up to 5 days spent in the Vanderbilt University Medical Center, at least one day of screening tests, followed by 2 study days.
Screening tests include a physical examination and history, routine safety laboratory assessments, and testing of the autonomic nervous system. Medications affecting blood pressure and the autonomic nervous system such as pressor medications will be withdrawn for at least 5 half-lives before studies, except for fludrocortisone. Other medications will be held constant throughout the study.
Eligible participants will then be studied on two separate days in random order: one day with midodrine combined with sham abdominal compression, and one day with abdominal compression combined with a placebo pill.
On each study day, participants will be instrumented to measure blood pressure, heart rate, hemodynamic parameters, segmental impedance, and markers of cardiovascular risk. A baseline tilt table test will be performed to obtain supine and upright baseline measurements, including the assessment of orthostatic symptoms. Participants will then receive a single oral dose of placebo or midodrine, and a deflated binder will be placed around the abdomen. Thirty to sixty minutes later, a second tilt table test will be done with sham or active abdominal compression. Outcome measurements will be repeated in the supine and upright positions. At the end of the second tilt table test, the investigators may also assess splanchnic venous capacitance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-blind, crossover
| Arm | Type | Receives |
|---|---|---|
| Midodrine day followed by abdominal compression day | Experimental | Drug: Midodrine, Device: sham compressionSingle oral dose of midodrine (5-10mg) combined with sham abdominal compression on the first study day followed by active abdominal compression (40 mmHg) combined with placebo pill. |
| Abdominal Compression study day followed by midodrine study day | Experimental | Drug: Placebo pill, Device: Abdominal compressionStudy day with abdominal compression (40 mmHg) combined with a placebo pill followed by study day with a single oral dose of midodrine (5-10mg) combined with sham abdominal compression. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrineMidodrine 5-10 mg, single oral dose | Drug | Midodrine day followed by abdominal compression day |
| Placebo pillAlso: sugar pillsingle oral dose | Drug | Abdominal Compression study day followed by midodrine study day |
| Abdominal compressionabdominal compression up to 40 mmHg during head-up tilt | Device | Abdominal Compression study day followed by midodrine study day |
| sham compressionSham abdominal compression during head-up tilt | Device | Midodrine day followed by abdominal compression day |
Primary outcome
Augmentation Index
Time frame: 1 hour post-intervention tilt table test
Change from baseline in upright augmentation index, used as a marker of cardiovascular risk associated with systemic arterial stiffness, wave reflection, and the resulting pulsatile workload imposed on the left ventricle. Higher values suggest greater risk.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Orthostatic Hypotension
Active, not recruitingPhase 2
A Study in Subjects With Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Not yet recruiting
Spinal Cord Stimulation for Neurogenic Orthostatic Hypotension
Neurogenic Orthostatic Hypotension
Not yet recruitingObservational study
Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study
Parkinson Disease (PD), REM Sleep Behavior Disorder (iRBD)
Recruiting
Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
Orthostatic; Hypotension, Neurogenic, Autonomic Failure
RecruitingObservational study
Natural History Study of Synucleinopathies
Patients With Synucleinopathies, Neurogenic Orthostatic Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Okamoto, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Midodrine and Abdominal compression in people with Neurogenic Orthostatic Hypotension and Autonomic Failure, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Augmentation Index (time frame: 1 hour post-intervention tilt table test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.