Ascites Hepatic, Cirrhosis, Liver, Portal Hypertension
Conditions
Brief summary
This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.
Detailed description
This is a feasibility trial to determine the feasibility of using home monitoring devices (e.g. blood pressure cuffs) to improve outcomes for cirrhosis patients.
Interventions
DEVICEWithings Home Blood Pressure Device and Scale
The intervention will be whether the data generated from home monitoring devices are shared with the clinical providers. The investigators are not testing the efficacy of these approved devices.
OTHERStandard of Care
Standard of Care
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Arterial Pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ascites Burden | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 35 |
| Total | 69 |
Baseline characteristics
| Characteristic | Standard of Care | Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 2 | 61 years STANDARD_DEVIATION 3 | 62 years STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 11 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 24 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mean Arterial Pressure (MAP) in mmHg | 75 mmHg STANDARD_DEVIATION 5 | 77 mmHg STANDARD_DEVIATION 6 | 76 mmHg STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 35 |
| other Total, other adverse events | 0 / 34 | 0 / 35 |
| serious Total, serious adverse events | 0 / 34 | 0 / 35 |
Outcome results
Primary
Change in Mean Arterial Pressure
The investigators will compare the change in mean arterial pressure before and after utilization of the data generated from the home monitoring.
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change in Mean Arterial Pressure | 0.5 mmHg | Standard Deviation 3.2 |
| Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions | Change in Mean Arterial Pressure | 1 mmHg | Standard Deviation 4.1 |
Secondary
Change in Ascites Burden
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.
Time frame: Baseline and 24 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change in Ascites Burden | 6.1 L | Standard Deviation 4.2 |
| Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions | Change in Ascites Burden | 4.7 L | Standard Deviation 5.1 |