A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients

Portal Hypertension Clinical Trial

— WATCH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928624
• Other study ID #: 22-36046
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Giuseppe Cullaro, MD, MAS
• Phone: 415 476 3143
• Email: giuseppe.cullaro[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients will need to have decompensated cirrhosis defined as a Child Pugh Score = 7

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic
• Cirrhosis, Liver
• Fibrosis
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Device:
• Withings 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.

Other:
• Standard of Care
Standard of Care

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and 24 Weeks
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.	Baseline and 24 Weeks