Cirrhosis, LiverWATCHNCT05928624
A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients
A study testing Withings Home Blood Pressure Device and Scale in people with Cirrhosis, Liver and Portal Hypertension, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Portal Hypertension, Ascites Hepatic
- What is being tested?
- Withings Home Blood Pressure Device and Scale
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to 1 Jul 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Wireless Automated Tracking in Cirrhosis Patients at Home (WATCH) Trial: A Randomized Single Blind Trial Testing the Use of Home Monitoring Among Decompensated Cirrhosis Patients
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.
Read the 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.
- Conditions
- Cirrhosis, Liver, Portal Hypertension, Ascites Hepatic
- Being tested
- Withings Home Blood Pressure Device and Scale, Standard of Care
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withings Home Blood Pressure Device and ScaleDevice
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.
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Sham comparator | 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. Receives: Other: Standard of Care |
| Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions | Experimental | 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. Receives: Device: Withings Home Blood Pressure Device and Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 Weeks
Secondary outcomes (1)
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.
Measured: Baseline and 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start22 Sep 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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 Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Cullaro, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928624
- Sponsor's protocol ID
- 22-36046
- Acronym
- WATCH
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2023
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Automated Tracking in Cirrhosis Patients at Home (WATCH) Trial: A Randomized Single Blind Trial Testing the Use of Home Monitoring Among Decompensated Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT05928624
- Acronym / sponsor ID
- WATCH / 22-36046
- Conditions
- Cirrhosis, Liver, Portal Hypertension, Ascites Hepatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Posted 22 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Sham comparator | Other: Standard of CareThis 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 | Experimental | Device: Withings Home Blood Pressure Device and ScaleThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will need to have decompensated cirrhosis defined as a Child Pugh Score ≥ 7
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Withings Home Blood Pressure Device and ScaleThe 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. | Device | Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions |
| Standard of CareStandard of Care | Other | Standard of Care |
Primary outcome
Change in Mean Arterial Pressure
Time frame: 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.
1 secondary outcome
Change in Ascites Burden
Time frame: Baseline and 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Giuseppe Cullaro, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withings Home Blood Pressure Device and Scale in people with Cirrhosis, Liver and Portal Hypertension, run by University of California, San Francisco 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 1 inclusion and 1 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 22 Jul 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2025). 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?
Change in Mean Arterial Pressure (time frame: Baseline and 24 Weeks). 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 22 Jul 2025.