Home Blood Pressure Monitoring for Liver Cirrhosis

(WATCH Trial)

Overseen By Hannah Chao

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Giuseppe Cullaro, MD, MAS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for patients with advanced liver cirrhosis (Child Pugh Score ≥ 7), which means their liver is severely scarred and not working well. The study aims to help manage their condition using home blood pressure monitoring.

Inclusion Criteria

My liver disease is severe, with a Child Pugh Score of 7 or higher.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use home blood pressure monitors and scales to inform clinical decisions

24 weeks

Weekly data review

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Withings Home Blood Pressure Device and Scale

Trial Overview The trial is testing if using a Withings Home Blood Pressure Device and Scale can improve the treatment of decompensated cirrhosis compared to standard care alone. It's a randomized single-blind study, meaning some patients will use the device while others won't, and they won't know which group they're in.

Participant Groups

Group I: Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+