Trial Outcomes & Findings for Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients (NCT NCT04620382)
NCT ID: NCT04620382
Last Updated: 2026-08-07
Results Overview
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.
COMPLETED
EARLY_PHASE1
31 participants
1 hour post-intervention tilt table test
2026-08-07
Participant Flow
31 subjects were enrolled and underwent screening procedures.
Of the 31 subjects enrolled, 9 subjects did not complete the study
Participant milestones
| Measure |
Midodrine Study Day Followed by Abdominal Compression Study Day
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.
|
Abdominal Compression Study Day Followed by Midodrine Study Day
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients
Baseline characteristics by cohort
| Measure |
Midodrine Study Day Followed by Abdominal Compression Study Day
n=11 Participants
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.
|
Abdominal Compression Study Day Followed by Midodrine Study Day
n=11 Participants
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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 6 • n=20 Participants
|
71 years
STANDARD_DEVIATION 9 • n=20 Participants
|
71 years
STANDARD_DEVIATION 8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Orthostatic drop in systolic blood pressure, mm Hg
|
-52 mm Hg
STANDARD_DEVIATION 21 • n=20 Participants
|
-61 mm Hg
STANDARD_DEVIATION 39 • n=20 Participants
|
-57 mm Hg
STANDARD_DEVIATION 29 • n=40 Participants
|
PRIMARY outcome
Timeframe: 1 hour post-intervention tilt table testChange 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.
Outcome measures
| Measure |
Midodrine
n=22 Participants
Single oral dose of midodrine (5-10mg) combined with sham abdominal compression
|
Abdominal Compression
n=22 Participants
active abdominal compression (40 mmHg) combined with placebo pill
|
|---|---|---|
|
Augmentation Index
|
30 Percentage
Standard Deviation 25
|
-20 Percentage
Standard Deviation 7
|
Adverse Events
Midodrine
Abdominal Compression
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place