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Home Blood Pressure Monitoring for Liver Cirrhosis (WATCH Trial)
N/A
Recruiting
Led By Giuseppe Cullaro, MD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 weeks
Summary
This trial tests if home blood pressure devices can help improve care for cirrhosis patients with severe symptoms.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on monitoring rather than medication, direct side effects from interventions are minimal. However, there may be indirect effects related to changes in management of midodrine based on blood pressure readings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Mean Arterial Pressure
Secondary study objectives
Change in Ascites Burden
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Home Blood Pressure and Scale Monitoring to Inform Clinical DecisionsExperimental Treatment1 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 CarePlacebo Group1 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.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,076 Total Patients Enrolled
8 Trials studying Liver Cirrhosis
4,913 Patients Enrolled for Liver Cirrhosis
Giuseppe Cullaro, MD, MASPrincipal InvestigatorUniversity of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- N/AMy liver disease is severe, with a Child Pugh Score of 7 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions
- Group 2: Standard of Care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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