Trial Outcomes & Findings for A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients (NCT NCT05928624)
NCT ID: NCT05928624
Last Updated: 2025-07-22
Results Overview
The investigators will compare the change in mean arterial pressure before and after utilization of the data generated from the home monitoring.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Baseline and 24 Weeks
Results posted on
2025-07-22
Participant Flow
Participant milestones
| Measure |
Standard of Care
This arm will receive a home blood pressure monitor and scale; however, these data will not be shared with their treating provider in real-time.
|
Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions
This arm will receive a home blood pressure monitor and scale. These data will be reviewed weekly and these data will be shared with the treating provider to inform clinical decisions.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
|
Overall Study
COMPLETED
|
34
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients
Baseline characteristics by cohort
| Measure |
Standard of Care
n=34 Participants
This arm will receive a home blood pressure monitor and scale; however, these data will not be shared with their treating provider in real-time.
|
Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions
n=35 Participants
This arm will receive a home blood pressure monitor and scale. These data will be reviewed weekly and these data will be shared with the treating provider to inform clinical decisions.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 2 • n=99 Participants
|
61 years
STANDARD_DEVIATION 3 • n=107 Participants
|
62 years
STANDARD_DEVIATION 2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Mean Arterial Pressure (MAP) in mmHg
|
75 mmHg
STANDARD_DEVIATION 5 • n=99 Participants
|
77 mmHg
STANDARD_DEVIATION 6 • n=107 Participants
|
76 mmHg
STANDARD_DEVIATION 5 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 WeeksThe investigators will compare the change in mean arterial pressure before and after utilization of the data generated from the home monitoring.
Outcome measures
| Measure |
Standard of Care
n=34 Participants
This arm will receive a home blood pressure monitor and scale; however, these data will not be shared with their treating provider in real-time.
|
Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions
n=35 Participants
This arm will receive a home blood pressure monitor and scale. These data will be reviewed weekly and these data will be shared with the treating provider to inform clinical decisions.
|
|---|---|---|
|
Change in Mean Arterial Pressure
|
0.5 mmHg
Standard Deviation 3.2
|
1 mmHg
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksThe investigators will compare the change in ascites burden, defined as the total volume of ascites removed during the study period, before and after utilization of the data generated from the home monitoring.
Outcome measures
| Measure |
Standard of Care
n=34 Participants
This arm will receive a home blood pressure monitor and scale; however, these data will not be shared with their treating provider in real-time.
|
Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions
n=35 Participants
This arm will receive a home blood pressure monitor and scale. These data will be reviewed weekly and these data will be shared with the treating provider to inform clinical decisions.
|
|---|---|---|
|
Change in Ascites Burden
|
6.1 L
Standard Deviation 4.2
|
4.7 L
Standard Deviation 5.1
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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