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=5 Participants	61 years STANDARD_DEVIATION 3 • n=7 Participants	62 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Mean Arterial Pressure (MAP) in mmHg	75 mmHg STANDARD_DEVIATION 5 • n=5 Participants	77 mmHg STANDARD_DEVIATION 6 • n=7 Participants	76 mmHg STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 Weeks

The 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 Weeks

The 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

Giuseppe Cullaro, MD MAS

Columbia University

Phone: 8454067438

Email: gc2576@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place