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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
Awards & highlights

WATCH Trial 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.Check my eligibility
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.See study design
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.

WATCH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Mean Arterial Pressure
Secondary outcome measures
Change in Ascites Burden

WATCH 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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,475 Total Patients Enrolled
Giuseppe Cullaro, MD, MASPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions Clinical Trial Eligibility Overview. Trial Name: NCT05928624 — N/A
Ascites Research Study Groups: Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions, Standard of Care
Ascites Clinical Trial 2023: Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions Highlights & Side Effects. Trial Name: NCT05928624 — N/A
Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions 2023 Treatment Timeline for Medical Study. Trial Name: NCT05928624 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for participation in this research endeavor?

"According to the clinicaltrials.gov database, this research is currently recruiting participants and has been updated since its initial posting on June 15th 2023. The most recent edit was made on June 30th 2023."

Answered by AI

How many participants are being recruited for this research project?

"Affirmative. According to clinicaltrials.gov, this medical trial is actively enrolling patients; it was first posted on June 15th 2023 and last updated one fortnight later. 100 people are required from a single site for the study's successful completion."

Answered by AI
~22 spots leftby Jul 2024