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

Not Applicable

Completed

• Conditions: Portal Hypertension; Ascites Hepatic; Cirrhosis, Liver
• Interventions: Device: Withings Home Blood Pressure Device and Scale; Other: Standard of Care

• Registration Number: NCT05928624
• Lead Sponsor: University of California, San Francisco

Brief 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.

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 Timeline

• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-03
• Study Start: 2023-09-22
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Blood Pressure and Scale Monitoring to Inform Clinical Decisions	Withings Home Blood Pressure Device and Scale	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.
Standard of Care	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Change in Mean Arterial Pressure	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.

Secondary Outcome Measures

Name	Time	Method
Change in Ascites Burden	Baseline and 24 Weeks	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.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States